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shall follow the scenarios as outlined below: \\\\\n- Subjects having undergone TAVI without other potential indications for antiplatelet therapy (APT) may obtain either no APT or single antiplatelet therapy (SAPT) up to 90 days, i.e., acetylsalicylic acid (ASA) or any P2Y \\({ }_{12}\\) inhibitor (preferably clopidogrel). \\\\\n- Subjects having undergone TAVI with percutaneous coronary intervention (PCI) either prior to or during the study period may obtain SAPT indefinitely, i.e., any \\(P 2_{12} Y _{12}\\) inhibitor (preferably clopidogrel) or ASA. Dual anti-platelet therapy (DAPT) is only allowed post stenting for up to 3 months after each PCI during this study. \\\\\n- Subjects having undergone TAVI with other potential indications for oral antiplatelet therapy may obtain either no APT or SAPT, i.e., any P2Y \\({ }_{12}\\) inhibitor (preferably clopidogrel) or ASA indefinitely.\n\\end{tabular} \\\\\n\\hline & The type (i.e., the international nonproprietary name, the dose, and the projected last dose of all antiplatelet agents) must be predeclared at randomization. ASA \\(7 5 - 1 0 0 ~ m g / d a y\\) or generic/branded clopidogrel \\(7 5 ~ m g /\\) day (chronic therapy following loading dose) are the preferred agents. Type, dose, and (projected) last dose may be changed during the treatment period for documented medical reasons. \\\\\n\\hline Study Duration: & Subjects will be monitored throughout the entire study period regardless of whether they have or have not experienced an endpoint. Monitoring will be performed with study visits (which can be on-site or at the subject's current place of living, but the monitoring will be conducted by the Investigator or qualified designee) at 3 and 6 months post randomization, then semi-annually, at the end of the treatment period, and at 30 days after the last dose of the study medication (see Table 17.1). After the End of Treatment Visit, subjects will have the option to be followed by telephone contact with the site and/or review of their \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline & [Japan: 1.6 to 2.6 in subjects aged \\(\\geq 70\\) (numbers inclusive)]. \\\\\n\\hline & \\begin{tabular}{l}\nIn addition to the above described oral anticoagulation therapy, antiplatelet management in this study shall follow the scenarios as outlined below: \\\\\n- Subjects having undergone TAVI without other potential indications for antiplatelet therapy (APT) may obtain either no APT or single antiplatelet therapy (SAPT) up to 90 days, i.e., acetylsalicylic acid (ASA) or any P2Y \\({ }_{12}\\) inhibitor (preferably clopidogrel). \\\\\n- Subjects having undergone TAVI with percutaneous coronary intervention (PCI) either prior to or during the study period may obtain SAPT indefinitely, i.e., any \\(P 2_{12} Y _{12}\\) inhibitor (preferably clopidogrel) or ASA. Dual anti-platelet therapy (DAPT) is only allowed post stenting for up to 3 months after each PCI during this study. \\\\\n- Subjects having undergone TAVI with other potential indications for oral antiplatelet therapy may obtain either no APT or SAPT, i.e., any P2Y \\({ }_{12}\\) inhibitor (preferably clopidogrel) or ASA indefinitely.\n\\end{tabular} \\\\\n\\hline & The type (i.e., the international nonproprietary name, the dose, and the projected last dose of all antiplatelet agents) must be predeclared at randomization. ASA \\(7 5 - 1 0 0 ~ m g / d a y\\) or generic/branded clopidogrel \\(7 5 ~ m g /\\) day (chronic therapy following loading dose) are the preferred agents. Type, dose, and (projected) last dose may be changed during the treatment period for documented medical reasons. \\\\\n\\hline Study Duration: & Subjects will be monitored throughout the entire study period regardless of whether they have or have not experienced an endpoint. 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clinical outcomes. \\({ }^{5,6}\\)","text_display":" insufficiency/aortic valve regurgitation has also provided efficacious clinical outcomes. \\({ }^{5,6}\\)","confidence":0.99853515625,"confidence_rate":0.9999859047370074},{"cnt":[[309,765],[1766,765],[1766,814],[309,814]],"region":{"top_left_x":309,"top_left_y":764,"width":1458,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"077c9d75389f4db58b32581155e3954f","type":"text","conversion_output":true,"text":"The safety and effectiveness of TAVI compared with surgical aortic valve replacement","text_display":" The safety and effectiveness of TAVI compared with surgical aortic valve replacement","confidence":1,"confidence_rate":1},{"cnt":[[309,816],[1635,816],[1635,862],[309,862]],"region":{"top_left_x":309,"top_left_y":816,"width":1326,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd6f1fcc47b148e0a76098e9528b21c1","type":"text","conversion_output":true,"text":"has been demonstrated in clinical randomized trials using both of the two most","text_display":" has been demonstrated in clinical randomized trials using both of the two most","confidence":1,"confidence_rate":1},{"cnt":[[309,864],[1760,864],[1760,909],[309,909]],"region":{"top_left_x":309,"top_left_y":863,"width":1451,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"875efbcc7f5345608fa6a4eea9e65e12","type":"text","conversion_output":true,"text":"commonly used TAVI devices, the balloon-expandable Edwards Sapien / SAPIEN XT","text_display":" commonly used TAVI devices, the balloon-expandable Edwards Sapien / SAPIEN XT","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[309,911],[1622,911],[1622,960],[309,960]],"region":{"top_left_x":309,"top_left_y":910,"width":1314,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"471412603b9d4cab9042ec2dbdb769e7","type":"text","conversion_output":true,"text":"valve (Edwards Sapien, CA) and the Medtronic Core Valve Revalving System","text_display":" valve (Edwards Sapien, CA) and the Medtronic Core Valve Revalving System","confidence":1,"confidence_rate":1},{"cnt":[[309,958],[829,958],[829,1008],[309,1008]],"region":{"top_left_x":309,"top_left_y":958,"width":521,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c523ce7631394e6085b8956f40a12172","type":"text","conversion_output":true,"text":"(Medtronic Inc., CA) (4-6). \\({ }^{4,7,8}\\)","text_display":" (Medtronic Inc., CA) (4-6). \\({ 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As compared to percutaneous coronary interventions (PCI), this risk is at least","text_display":" concern. As compared to percutaneous coronary interventions (PCI), this risk is at least","confidence":1,"confidence_rate":1},{"cnt":[[312,1121],[1790,1121],[1790,1171],[312,1171]],"region":{"top_left_x":311,"top_left_y":1121,"width":1479,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28ee9cd8a6114e769d4f6e1e6c7bca20","type":"text","conversion_output":true,"text":"10-fold higher for TAVI. \\({ }^{9}\\) Patients undergoing TAVI are elder, frail, and at high risk for","text_display":" 10-fold higher for TAVI. \\({ }^{9}\\) Patients undergoing TAVI are elder, frail, and at high risk for","confidence":1,"confidence_rate":1},{"cnt":[[309,1173],[1783,1173],[1783,1222],[309,1222]],"region":{"top_left_x":309,"top_left_y":1173,"width":1475,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb8182394bc2435aa13eb990aff63e33","type":"text","conversion_output":true,"text":"both stroke (high \\(CHA _{2} DS _{2}\\)-VASc score or CHADS \\({ }_{2}\\) ) and bleeding (high HAS-BLEED","text_display":" both stroke (high \\(CHA _{2} DS _{2}\\)-VASc score or CHADS \\({ }_{2}\\) ) and bleeding (high HAS-BLEED","confidence":0.9594217673875391,"confidence_rate":0.9996460071007963},{"cnt":[[309,1220],[1704,1220],[1704,1270],[309,1270]],"region":{"top_left_x":309,"top_left_y":1220,"width":1395,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5cfe8d849193466cb99f9af970c33645","type":"text","conversion_output":true,"text":"Score) though at present, studies are underway, that compare the outcome of TAVI","text_display":" Score) though at present, studies are underway, that compare the outcome of TAVI","confidence":1,"confidence_rate":1},{"cnt":[[309,1265],[1738,1265],[1738,1317],[309,1317]],"region":{"top_left_x":309,"top_left_y":1265,"width":1430,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90830d383883441f84902a7d03c0e262","type":"text","conversion_output":true,"text":"versus surgical valve replacement in patients of less overall risk. \\({ }^{10}\\) This risk increases","text_display":" versus surgical valve replacement in patients of less overall risk. \\({ }^{10}\\) This risk increases","confidence":1,"confidence_rate":1},{"cnt":[[309,1317],[1607,1317],[1607,1364],[309,1364]],"region":{"top_left_x":309,"top_left_y":1316,"width":1299,"height":49},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a40db450b3bc400086cb2fa87fc24fce","type":"text","conversion_output":true,"text":"exponentially in patients with atrial fibrillation or other indications to chronic","text_display":" exponentially in patients with atrial fibrillation or other indications to chronic","confidence":1,"confidence_rate":1},{"cnt":[[309,1366],[1751,1366],[1751,1412],[309,1412]],"region":{"top_left_x":309,"top_left_y":1366,"width":1442,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee7d5ef2a79d40c6b1abbb5b4d89d88a","type":"text","conversion_output":true,"text":"anticoagulation therapy. Balancing the risk of both bleeding and thrombotic events in","text_display":" anticoagulation therapy. Balancing the risk of both bleeding and thrombotic events in","confidence":1,"confidence_rate":1},{"cnt":[[309,1414],[1768,1414],[1768,1463],[309,1463]],"region":{"top_left_x":309,"top_left_y":1413,"width":1460,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"348b4a2e9a1e4734ab4de02d59d3d0d3","type":"text","conversion_output":true,"text":"this population is challenging. Moreover, optimal antithrombotic therapy after TAVI is","text_display":" this population is challenging. 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Furthermore, new-onset atrial fibrillation may account for many episodes","text_display":" implantation. Furthermore, new-onset atrial fibrillation may account for many episodes","confidence":1,"confidence_rate":1},{"cnt":[[309,1656],[1749,1656],[1749,1704],[309,1704]],"region":{"top_left_x":309,"top_left_y":1656,"width":1440,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1030d4bd1ece41aab4258d59f1c4e660","type":"text","conversion_output":true,"text":"of stroke at distance from the TAVI procedure. Bleeding complications are associated","text_display":" of stroke at distance from the TAVI procedure. 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Therefore, the use of a direct factor Xa inhibitor such as Edoxaban in","text_display":" atrial fibrillation. Therefore, the use of a direct factor Xa inhibitor such as Edoxaban in","confidence":0.955078125,"confidence_rate":0.9995494923368632},{"cnt":[[309,2241],[1540,2241],[1540,2288],[309,2288]],"region":{"top_left_x":309,"top_left_y":2240,"width":1232,"height":49},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12e6578c8ef64382b2c7dee0387acad1","type":"text","conversion_output":true,"text":"patients undergoing TAVI may be an attractive option in order to prevent","text_display":" patients undergoing TAVI may be an attractive option in order to prevent","confidence":1,"confidence_rate":1},{"cnt":[[309,2290],[941,2290],[941,2340],[309,2340]],"region":{"top_left_x":309,"top_left_y":2290,"width":633,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57abeb1ec9ee46589895158ee686d2a3","type":"text","conversion_output":true,"text":"thromboembolic and bleeding events.","text_display":" thromboembolic and bleeding events.","confidence":1,"confidence_rate":1},{"cnt":[[309,2359],[1699,2359],[1699,2406],[309,2406]],"region":{"top_left_x":309,"top_left_y":2358,"width":1391,"height":49},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"062c43fe2d534460aad3ef727b193a8e","type":"text","conversion_output":true,"text":"Periprocedural access-site bleeding after TAVI is common and is associated with a","text_display":"\n\nPeriprocedural access-site bleeding after TAVI is common and is associated with a","confidence":1,"confidence_rate":1},{"cnt":[[309,2406],[1792,2406],[1792,2456],[309,2456]],"region":{"top_left_x":309,"top_left_y":2406,"width":1483,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"092fd8023dc14c09833efa11e125b9ee","type":"text","conversion_output":true,"text":"significant impact on morbidity and mortality. Given the advanced age and the presence","text_display":" significant impact on morbidity and mortality. 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Généreux et al. in a pooled analysis from the PARTNER trials and","text_display":" (> 30 days) bleeding. 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The MLBCs occurring","confidence":1,"confidence_rate":1},{"cnt":[[309,690],[1712,690],[1712,737],[309,737]],"region":{"top_left_x":309,"top_left_y":689,"width":1404,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07c9b896cbea423497243bffd4a737a2","type":"text","conversion_output":true,"text":"between 30 days and 1 year were associated with significantly higher rates of death,","text_display":" between 30 days and 1 year were associated with significantly higher rates of death,","confidence":1,"confidence_rate":1},{"cnt":[[309,739],[1781,739],[1781,784],[309,784]],"region":{"top_left_x":309,"top_left_y":739,"width":1473,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32d2824d52b647b2bbb5fbc43c00dbfd","type":"text","conversion_output":true,"text":"cardiac death, major stroke, renal failure and rehospitalization. The MLBC was a strong","text_display":" cardiac death, major stroke, renal failure and rehospitalization. The MLBC was a strong","confidence":1,"confidence_rate":1},{"cnt":[[309,786],[1721,786],[1721,834],[309,834]],"region":{"top_left_x":309,"top_left_y":786,"width":1412,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bbef68396c584ac09194d9c42f85a5fd","type":"text","conversion_output":true,"text":"independent predictor of mortality between 30 days and 1 year. The presence of AF ,","text_display":" independent predictor of mortality between 30 days and 1 year. The presence of AF ,","confidence":0.9902429580688477,"confidence_rate":0.999901955268985},{"cnt":[[309,834],[1803,834],[1803,883],[309,883]],"region":{"top_left_x":309,"top_left_y":833,"width":1494,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43246cb666754662a641b1676f96c8e3","type":"text","conversion_output":true,"text":"especially when MLBCs occurred, was associated with a poor prognosis and high rate of","text_display":" especially when MLBCs occurred, was associated with a poor prognosis and high rate of","confidence":1,"confidence_rate":1},{"cnt":[[309,885],[475,885],[475,930],[309,930]],"region":{"top_left_x":309,"top_left_y":885,"width":166,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2a678aa1f2a47ba9394f2122022e736","type":"text","conversion_output":true,"text":"mortality.","text_display":" 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widely accepted for patients","confidence":0.9990234375,"confidence_rate":0.9999896060152111},{"cnt":[[309,1042],[1704,1042],[1704,1094],[309,1094]],"region":{"top_left_x":309,"top_left_y":1041,"width":1395,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0e67270ba1774bed86ad5ea90846c62d","type":"text","conversion_output":true,"text":"undergoing TAVI. \\({ }^{12}\\) However, a randomized single-center study could not find any","text_display":" undergoing TAVI. \\({ }^{12}\\) However, a randomized single-center study could not find any","confidence":1,"confidence_rate":1},{"cnt":[[309,1096],[1800,1096],[1800,1141],[309,1141]],"region":{"top_left_x":309,"top_left_y":1095,"width":1492,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af1f7f6ea676434d87ea84bab8d25f0d","type":"text","conversion_output":true,"text":"benefit in patients treated with DAPT for 3 months post TAVI with regards to the risk of","text_display":" benefit in patients treated with DAPT for 3 months post TAVI with regards to the risk of","confidence":1,"confidence_rate":1},{"cnt":[[309,1139],[1811,1139],[1811,1190],[309,1190]],"region":{"top_left_x":309,"top_left_y":1138,"width":1503,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"864426495e924c6eb9ad57f7b6f31454","type":"text","conversion_output":true,"text":"cerebrovascular events or major adverse cardiac events compared to ASA monotherapy. \\({ }^{13}\\)","text_display":" cerebrovascular events or major adverse cardiac events compared to ASA monotherapy. \\({ }^{13}\\)","confidence":1,"confidence_rate":1},{"cnt":[[309,1192],[1717,1192],[1717,1240],[309,1240]],"region":{"top_left_x":309,"top_left_y":1192,"width":1408,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88c27cb8713d446faa0d2be9bc808646","type":"text","conversion_output":true,"text":"Thus, to date the optimal strategy and in particular pharmacological intervention for","text_display":" Thus, to date the optimal strategy and in particular pharmacological intervention for","confidence":1,"confidence_rate":1},{"cnt":[[309,1242],[1433,1242],[1433,1287],[309,1287]],"region":{"top_left_x":309,"top_left_y":1241,"width":1125,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f53b691ada33489bba981b82042aa50d","type":"text","conversion_output":true,"text":"reducing the risk of cerebrovascular events post TAVI is unknown.","text_display":" reducing the risk of cerebrovascular events post TAVI is unknown.","confidence":1,"confidence_rate":1},{"cnt":[[309,1311],[1768,1311],[1768,1360],[309,1360]],"region":{"top_left_x":309,"top_left_y":1310,"width":1460,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bf73dd92d04403985ae9844e95dd64b","type":"text","conversion_output":true,"text":"Antithrombotic treatment is believed to be a cornerstone for the prevention of ischemic","text_display":"\n\nAntithrombotic treatment is believed to be a cornerstone for the prevention of ischemic","confidence":0.9780378341674805,"confidence_rate":0.9997586495160983},{"cnt":[[309,1360],[1639,1360],[1639,1407],[309,1407]],"region":{"top_left_x":309,"top_left_y":1359,"width":1331,"height":49},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78f80e62ffe24943973d304df34c3525","type":"text","conversion_output":true,"text":"cerebrovascular accidents during and post TAVI. Current recommendations for","text_display":" cerebrovascular accidents during and post TAVI. Current recommendations for","confidence":1,"confidence_rate":1},{"cnt":[[309,1409],[1639,1409],[1639,1454],[309,1454]],"region":{"top_left_x":309,"top_left_y":1409,"width":1331,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"732ba1c378b54ddfa7b4bd7f61b58512","type":"text","conversion_output":true,"text":"antithrombotic agents and strategies for TAVI are not based on large controlled","text_display":" antithrombotic agents and strategies for TAVI are not based on large controlled","confidence":1,"confidence_rate":1},{"cnt":[[309,1452],[1734,1452],[1734,1502],[309,1502]],"region":{"top_left_x":309,"top_left_y":1452,"width":1425,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95a1aadeb73746279dd59d423e6ad00b","type":"text","conversion_output":true,"text":"randomized studies. \\({ }^{12,13,14,15,16,17}\\) There is an unmet need for improved antithrombotic","text_display":" randomized studies. \\({ }^{12,13,14,15,16,17}\\) There is an unmet need for improved antithrombotic","confidence":1,"confidence_rate":1},{"cnt":[[309,1504],[1790,1504],[1790,1551],[309,1551]],"region":{"top_left_x":309,"top_left_y":1503,"width":1481,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d01be15f8c5f4453bb8bce7c658b2fc2","type":"text","conversion_output":true,"text":"therapies and strategies given the fact that the incidence of major stroke has not declined","text_display":" therapies and strategies given the fact that the incidence of major stroke has not declined","confidence":1,"confidence_rate":1},{"cnt":[[309,1553],[1762,1553],[1762,1601],[309,1601]],"region":{"top_left_x":309,"top_left_y":1553,"width":1453,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4836efd03de4097893265c5d747ba20","type":"text","conversion_output":true,"text":"significantly overtime. In PARTNER, heparin was used for procedural anticoagulation","text_display":" significantly overtime. In PARTNER, heparin was used for procedural anticoagulation","confidence":1,"confidence_rate":1},{"cnt":[[309,1603],[1674,1603],[1674,1648],[309,1648]],"region":{"top_left_x":309,"top_left_y":1602,"width":1365,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c9bbf07f1a64bf6b94142b67885e7b5","type":"text","conversion_output":true,"text":"(5000 bolus loading dose) with a target of activated clotting time \\(>250 s\\), whereas","text_display":" (5000 bolus loading dose) with a target of activated clotting time \\(>250 s\\), whereas","confidence":0.9907307624816895,"confidence_rate":0.9998998709892996},{"cnt":[[309,1650],[1669,1650],[1669,1695],[309,1695]],"region":{"top_left_x":309,"top_left_y":1650,"width":1361,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53acc393eb66459aa25c1da08893f86d","type":"text","conversion_output":true,"text":"guidelines recommend a target time of 300 s . Similarly, dual antiplatelet therapy","text_display":" guidelines recommend a target time of 300 s . Similarly, dual antiplatelet therapy","confidence":0.9697265625,"confidence_rate":0.9996659129765211},{"cnt":[[309,1697],[1760,1697],[1760,1745],[309,1745]],"region":{"top_left_x":309,"top_left_y":1697,"width":1451,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c712ddc0eb3741c1aa9aae5da0a7dfa8","type":"text","conversion_output":true,"text":"(loading dose, maintenance dose, duration) after TAVI has not been explicitly defined.","text_display":" (loading dose, maintenance dose, duration) after TAVI has not been explicitly defined.","confidence":1,"confidence_rate":1},{"cnt":[[309,1747],[1704,1747],[1704,1794],[309,1794]],"region":{"top_left_x":309,"top_left_y":1746,"width":1395,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"247afff0ee6646058d49a49d325d7320","type":"text","conversion_output":true,"text":"PARTNER recommendation was \\(75-100 mg\\) of daily aspirin, a 300 mg clopidogrel","text_display":" PARTNER recommendation was \\(75-100 mg\\) of daily aspirin, a 300 mg clopidogrel","confidence":1,"confidence_rate":1},{"cnt":[[309,1790],[1644,1790],[1644,1841],[309,1841]],"region":{"top_left_x":309,"top_left_y":1789,"width":1335,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72ae6a6186d74fd9b0e23ce16047f3f3","type":"text","conversion_output":true,"text":"loading dose and 75 mg once-daily for 6 months following TAVI. \\({ }^{14,15}\\) However","text_display":" loading dose and 75 mg once-daily for 6 months following TAVI. \\({ }^{14,15}\\) However","confidence":1,"confidence_rate":1},{"cnt":[[309,1843],[1794,1843],[1794,1893],[309,1893]],"region":{"top_left_x":309,"top_left_y":1843,"width":1485,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"266843546d4c42cfa7257ccd0e12e4c5","type":"text","conversion_output":true,"text":"clopidogrel duration or loading dose are not specifically defined in guidelines, and lately","text_display":" clopidogrel duration or loading dose are not specifically defined in guidelines, and lately","confidence":1,"confidence_rate":1},{"cnt":[[309,1938],[309,1891],[1661,1893],[1661,1940]],"region":{"top_left_x":309,"top_left_y":1890,"width":1352,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d26a1ed33d84bf98c281bfa2a878f3a","type":"text","conversion_output":true,"text":"the general usefulness of clopidogrel on top of aspirin in TAVI patients has been","text_display":" the general usefulness of clopidogrel on top of aspirin in TAVI patients has 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clopidogrel, DAPT did not reduce the incidence of new cerebrovascular","confidence":1,"confidence_rate":1},{"cnt":[[309,2037],[1790,2037],[1790,2082],[309,2082]],"region":{"top_left_x":309,"top_left_y":2036,"width":1481,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1be67a2429754a62a9ac9cf7a55404cf","type":"text","conversion_output":true,"text":"accidents but was associated with significantly higher rates of major and life-threatening","text_display":" accidents but was associated with significantly higher rates of major and life-threatening","confidence":1,"confidence_rate":1},{"cnt":[[309,2080],[1738,2080],[1738,2133],[309,2133]],"region":{"top_left_x":309,"top_left_y":2079,"width":1430,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b60cba386d14447681803d1b0552c739","type":"text","conversion_output":true,"text":"bleeding complications. \\({ }^{13,17}\\) Since it is unclear whether thrombi produced during and","text_display":" bleeding complications. \\({ }^{13,17}\\) Since it is unclear whether thrombi produced during and","confidence":1,"confidence_rate":1},{"cnt":[[309,2133],[1777,2133],[1777,2181],[309,2181]],"region":{"top_left_x":309,"top_left_y":2133,"width":1468,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af79fc8a4a214b3d91fa505a3af65428","type":"text","conversion_output":true,"text":"after TAVI are of platelet or thrombin based origin, the latter may not favor clopidogrel","text_display":" after TAVI are of platelet or thrombin based origin, the latter may not favor clopidogrel","confidence":1,"confidence_rate":1},{"cnt":[[309,2183],[943,2183],[943,2228],[309,2228]],"region":{"top_left_x":309,"top_left_y":2182,"width":635,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9fa11bfa0a7400b9f2d2310e198092a","type":"text","conversion_output":true,"text":"as an 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Edoxaban has not been evaluated in patients with AF undergoing TAVI but","text_display":" for this trial. 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Whereas the concomitant use of OACs with antiplatelet agents reduces the","text_display":" and mortality. 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At present (2017) there are only limited","text_display":" non-valvular AF subjects after successful TAVI. At present (2017) there are only limited","confidence":1,"confidence_rate":1},{"cnt":[[309,2041],[1779,2041],[1779,2086],[309,2086]],"region":{"top_left_x":309,"top_left_y":2041,"width":1470,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"602c9755b8884c138128a7251cab3ca0","type":"text","conversion_output":true,"text":"data and no consensus among experts on how to best treat subject with non-valvular AF","text_display":" data and no consensus among experts on how to best treat subject with non-valvular AF","confidence":0.6513671875,"confidence_rate":0.9952481950546104},{"cnt":[[309,2088],[1796,2088],[1796,2133],[309,2133]],"region":{"top_left_x":309,"top_left_y":2088,"width":1488,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddf7acd101f44b63aedd49dddae287d5","type":"text","conversion_output":true,"text":"following successful TAVI procedures. 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for stent thrombosis.","confidence":1,"confidence_rate":1},{"cnt":[[305,417],[1491,417],[1491,466],[305,466]],"region":{"top_left_x":305,"top_left_y":416,"width":1187,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9aacf986235d498eb8530e510234a3d6","type":"text","conversion_output":true,"text":"The design of ENVISAGE-TAVI AF accounts for all of these options.","text_display":"\n\nThe design of ENVISAGE-TAVI AF accounts for all of these options.","confidence":1,"confidence_rate":1},{"cnt":[[821,2531],[1302,2531],[1302,2580],[821,2580]],"region":{"top_left_x":820,"top_left_y":2530,"width":482,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e66abf02d5c948cc9e0ee80a6ad66b3b","type":"page_info","conversion_output":false,"text":"Proprietary and 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While successful","text_display":" before any study-specific qualification procedures are conducted. While successful","confidence":1,"confidence_rate":1},{"cnt":[[309,425],[1708,425],[1708,473],[309,473]],"region":{"top_left_x":309,"top_left_y":425,"width":1400,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"658348686db74e0188a88b6304575728","type":"text","conversion_output":true,"text":"TAVI is a required inclusion criterion, the TAVI procedure is not part of this study;","text_display":" TAVI is a required inclusion criterion, the TAVI procedure is not part of this study;","confidence":1,"confidence_rate":1},{"cnt":[[309,475],[1697,475],[1697,522],[309,522]],"region":{"top_left_x":309,"top_left_y":474,"width":1389,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"def17fb260f94f9abd4788d8a9ee19d7","type":"text","conversion_output":true,"text":"however, information derived from the procedure will be documented and used for","text_display":" however, information derived from the procedure will be documented and used for","confidence":1,"confidence_rate":1},{"cnt":[[309,524],[675,524],[675,569],[309,569]],"region":{"top_left_x":309,"top_left_y":524,"width":366,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd5223fb19aa41d39f933e19be83b533","type":"text","conversion_output":true,"text":"analysis of this study.","text_display":" analysis of this study.","confidence":1,"confidence_rate":1},{"cnt":[[305,610],[874,610],[874,660],[305,660]],"region":{"top_left_x":305,"top_left_y":610,"width":570,"height":50},"line":11,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"0d3898a7a7bf47299cc4f62cf4df361e","type":"section_header","conversion_output":false,"children_ids":["73630b1f30074848af2a7a1a312ab6a2"],"text":"","text_display":""},{"cnt":[[309,614],[870,614],[870,657],[309,657]],"region":{"top_left_x":309,"top_left_y":614,"width":562,"height":44},"line":12,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"73630b1f30074848af2a7a1a312ab6a2","type":"text","conversion_output":true,"parent_id":"0d3898a7a7bf47299cc4f62cf4df361e","text":"4.1. 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apixaban\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999956392907747},{"cnt":[[336,1043],[680,1043],[680,1080],[336,1080]],"region":{"top_left_x":336,"top_left_y":1042,"width":345,"height":39},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"387cc16153e341f28063bbcbb45e7621","type":"text","conversion_output":false,"parent_id":"06e955ed253940b58baebb548b8e3837","text":"Other non-VKA OAC drugs","text_display":"Other non-VKA OAC drugs","confidence":0.99951171875,"confidence_rate":0.9999825572771935},{"cnt":[[340,1082],[510,1082],[510,1122],[340,1122]],"region":{"top_left_x":339,"top_left_y":1082,"width":171,"height":40},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8936b032aef748c09a98046c82093c23","type":"text","conversion_output":false,"parent_id":"06e955ed253940b58baebb548b8e3837","text":"- dabigatran","text_display":"\n- 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apixaban","confidence":1,"confidence_rate":1},{"cnt":[[721,1103],[845,1103],[845,1135],[721,1135]],"region":{"top_left_x":721,"top_left_y":1102,"width":125,"height":34},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81dfc5830f664fe587a1658fae271885","type":"simple_cell","conversion_output":false,"parent_id":"65c289b9141449008a4117535f207dad","text":"edoxaban","text_display":"edoxaban","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[879,1082],[1706,1082],[1706,1156],[879,1156]],"region":{"top_left_x":879,"top_left_y":1082,"width":828,"height":75},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc6a2eefdb124d06985457a826d2dae7","type":"complex_cell","conversion_output":false,"parent_id":"65c289b9141449008a4117535f207dad","children_ids":["3abc58f7cd3847869090bc6b0cb4b2c3","bfa904dd37c341d2b346a54e3dd786a9"],"text":"Discontinue the OAC and start edoxaban at the time of the next OAC dose.","text_display":"Discontinue the OAC and start edoxaban at the time of the next OAC dose.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[883,1086],[1703,1086],[1703,1122],[883,1122]],"region":{"top_left_x":882,"top_left_y":1085,"width":821,"height":37},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3abc58f7cd3847869090bc6b0cb4b2c3","type":"text","conversion_output":false,"parent_id":"cc6a2eefdb124d06985457a826d2dae7","text":"Discontinue the OAC and start edoxaban at the time of the next OAC","text_display":"Discontinue the OAC and start edoxaban at the time of the next OAC","confidence":1,"confidence_rate":1},{"cnt":[[883,1120],[950,1120],[950,1153],[883,1153]],"region":{"top_left_x":882,"top_left_y":1119,"width":68,"height":34},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bfa904dd37c341d2b346a54e3dd786a9","type":"text","conversion_output":false,"parent_id":"cc6a2eefdb124d06985457a826d2dae7","text":"dose.","text_display":" dose.","confidence":1,"confidence_rate":1},{"cnt":[[341,1333],[644,1333],[644,1371],[341,1371]],"region":{"top_left_x":341,"top_left_y":1333,"width":303,"height":38},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28e82bd76c4c45e786a266d8f556ceee","type":"simple_cell","conversion_output":false,"parent_id":"65c289b9141449008a4117535f207dad","text":"Parenteral anticoagulants","text_display":"Parenteral anticoagulants","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[725,1333],[847,1333],[847,1366],[725,1366]],"region":{"top_left_x":724,"top_left_y":1333,"width":123,"height":33},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da0e3466209042d490bed003734c28b3","type":"simple_cell","conversion_output":false,"parent_id":"65c289b9141449008a4117535f207dad","text":"edoxaban","text_display":"edoxaban","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[878,1223],[1708,1223],[1708,1477],[878,1477]],"region":{"top_left_x":877,"top_left_y":1223,"width":831,"height":255},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b40d3275b6c84853a0465eb12fcda60d","type":"complex_cell","conversion_output":false,"parent_id":"65c289b9141449008a4117535f207dad","children_ids":["d21c26a304ab4b7d96f75f520b5aeb29","7ba8384b8e204dce8cdcf272f46c733d","c730e91431774d2fac839b8a1aacb26e","6d749398c77f4c36ae6a5db6a902ac97","8e37ef6a3b22431eb16995929bea295a","05b950acec804db2aab06f6e38ef688b"],"text":"\\begin{tabular}{l}\nThese agents should not be administered simultaneously. \\\\\nSubcutaneous anticoagulant (i.e. LMWH, fondaparinux): discontinue subcutaneous anticoagulant and start edoxaban at the time of the next scheduled subcutaneous anticoagulant dose. \\\\\nIntravenous unfractionated heparin: \\\\\nDiscontinue the infusion and start edoxaban 4 hours later.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThese agents should not be administered simultaneously. \\\\\nSubcutaneous anticoagulant (i.e. LMWH, fondaparinux): discontinue subcutaneous anticoagulant and start edoxaban at the time of the next scheduled subcutaneous anticoagulant dose. \\\\\nIntravenous unfractionated heparin: \\\\\nDiscontinue the infusion and start edoxaban 4 hours later.\n\\end{tabular}","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[883,1226],[1557,1226],[1557,1263],[883,1263]],"region":{"top_left_x":882,"top_left_y":1226,"width":675,"height":37},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d21c26a304ab4b7d96f75f520b5aeb29","type":"text","conversion_output":false,"parent_id":"b40d3275b6c84853a0465eb12fcda60d","text":"These agents should not be administered simultaneously.","text_display":"These agents should not be administered simultaneously.","confidence":1,"confidence_rate":1},{"cnt":[[883,1261],[1703,1261],[1703,1300],[883,1300]],"region":{"top_left_x":882,"top_left_y":1260,"width":821,"height":41},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ba8384b8e204dce8cdcf272f46c733d","type":"text","conversion_output":false,"parent_id":"b40d3275b6c84853a0465eb12fcda60d","text":"Subcutaneous anticoagulant (i.e. LMWH, fondaparinux): discontinue","text_display":"\nSubcutaneous anticoagulant (i.e. LMWH, fondaparinux): discontinue","confidence":1,"confidence_rate":1},{"cnt":[[883,1297],[1704,1297],[1704,1333],[883,1333]],"region":{"top_left_x":882,"top_left_y":1296,"width":823,"height":38},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c730e91431774d2fac839b8a1aacb26e","type":"text","conversion_output":false,"parent_id":"b40d3275b6c84853a0465eb12fcda60d","text":"subcutaneous anticoagulant and start edoxaban at the time of the next","text_display":" subcutaneous anticoagulant and start edoxaban at the time of the next","confidence":1,"confidence_rate":1},{"cnt":[[883,1330],[1407,1330],[1407,1369],[883,1369]],"region":{"top_left_x":882,"top_left_y":1329,"width":526,"height":41},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d749398c77f4c36ae6a5db6a902ac97","type":"text","conversion_output":false,"parent_id":"b40d3275b6c84853a0465eb12fcda60d","text":"scheduled subcutaneous anticoagulant dose.","text_display":" scheduled subcutaneous anticoagulant dose.","confidence":1,"confidence_rate":1},{"cnt":[[883,1402],[1311,1402],[1311,1441],[883,1441]],"region":{"top_left_x":882,"top_left_y":1401,"width":429,"height":41},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e37ef6a3b22431eb16995929bea295a","type":"text","conversion_output":false,"parent_id":"b40d3275b6c84853a0465eb12fcda60d","text":"Intravenous unfractionated heparin:","text_display":"\nIntravenous unfractionated heparin:","confidence":1,"confidence_rate":1},{"cnt":[[883,1440],[1567,1440],[1567,1476],[883,1476]],"region":{"top_left_x":882,"top_left_y":1439,"width":685,"height":37},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05b950acec804db2aab06f6e38ef688b","type":"text","conversion_output":false,"parent_id":"b40d3275b6c84853a0465eb12fcda60d","text":"Discontinue the infusion and start edoxaban 4 hours later.","text_display":"\nDiscontinue the infusion and start edoxaban 4 hours later.","confidence":1,"confidence_rate":1},{"cnt":[[331,1500],[1695,1500],[1695,1543],[331,1543]],"region":{"top_left_x":330,"top_left_y":1499,"width":1366,"height":44},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a90ac3291378441386c0dbd38a8e5d83","type":"text","conversion_output":true,"text":"\\(INR =\\) international normalized ratio; \\(OAC =\\) Oral anticoagulant \\(( s ) ; VKA =\\) vitamin K antagonist","text_display":"\n\\(INR =\\) international normalized ratio; \\(OAC =\\) Oral anticoagulant \\(( s ) ; VKA =\\) vitamin K antagonist","confidence":0.19530100896618005,"confidence_rate":0.9862545528926075},{"cnt":[[301,1577],[1128,1577],[1128,1631],[301,1631]],"region":{"top_left_x":300,"top_left_y":1576,"width":828,"height":55},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48bc2997f5b049db94ca94b74e1135dc","type":"section_header","conversion_output":false,"children_ids":["bde6d392634e457e921a39345b9d142b"],"text":"","text_display":""},{"cnt":[[305,1581],[1124,1581],[1124,1626],[305,1626]],"region":{"top_left_x":305,"top_left_y":1581,"width":819,"height":46},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bde6d392634e457e921a39345b9d142b","type":"text","conversion_output":true,"parent_id":"48bc2997f5b049db94ca94b74e1135dc","text":"5.2.1.1.2. Transition from Edoxaban at EOT","text_display":"\n\n\\subsection*{5.2.1.1.2. Transition from Edoxaban at EOT}","confidence":1,"confidence_rate":1},{"cnt":[[305,1650],[1732,1650],[1732,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1650,"width":1427,"height":54},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbefcbe440b24a6ab58ce641ff1caae3","type":"text","conversion_output":true,"text":"For subjects randomized to the Edoxaban-based regimen that require switching from","text_display":"\n\nFor subjects randomized to the Edoxaban-based regimen that require switching from","confidence":0.9970703125,"confidence_rate":0.9999658844489859},{"cnt":[[305,1697],[1781,1697],[1781,1751],[305,1751]],"region":{"top_left_x":305,"top_left_y":1697,"width":1477,"height":54},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40014aee4e2745979df03fafd0df7e3c","type":"text","conversion_output":true,"text":"Edoxaban to another anticoagulant at the scheduled end of treatment (EOT) (or due to a","text_display":" Edoxaban to another anticoagulant at the scheduled end of treatment (EOT) (or due to a","confidence":1,"confidence_rate":1},{"cnt":[[305,1747],[1618,1747],[1618,1798],[305,1798]],"region":{"top_left_x":305,"top_left_y":1746,"width":1313,"height":53},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8ce1cad7b344658aad222bf37d39de3","type":"text","conversion_output":true,"text":"premature Edoxaban discontinuation) the following algorithm should be used:","text_display":" premature Edoxaban discontinuation) the following algorithm should be used:","confidence":0.9990234375,"confidence_rate":0.9999877870789805},{"cnt":[[301,1833],[1248,1833],[1248,1893],[301,1893]],"region":{"top_left_x":300,"top_left_y":1832,"width":949,"height":61},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5514626713b4064bc991b66d2bed3b9","type":"figure_label","conversion_output":false,"text":"Table 5.2: Transitioning from Edoxaban at EOT","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999902320377446},{"cnt":[[296,1899],[1830,1899],[1830,2488],[296,2488]],"region":{"top_left_x":296,"top_left_y":1899,"width":1535,"height":589},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"64ffb83c5ea14c3a88eb17ed03071b19","type":"table","conversion_output":true,"children_ids":["7442c934b20c429daf950b39109437c1","7d36090ac7e343b08cc16e71b5e26019","73c59858c2af4f8fb3424e0bd5d8f738","69d87bdf118b4303bdc05cf96fdcc025","3b95195e1b7a4a11ba93dcba6e017be5","63cae79ab501443eb3ee457aec359d60","f5da65e23b0c4c9784dccb2d1587f8a2","5f360f1cdd9049a78d41c7af7451b567","dcc2e93f794b499cb8ee5ed83ac96969","f77c913510ef479fad0688d896204da8","0d14f131a5a743cf9466f437ce8ace97","199b9fe06f33423ba2b89cba847c2630","b09d44667d7e40978c7c09b0daa376d1"],"selected_labels":["a5514626713b4064bc991b66d2bed3b9"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|c|}{Switching from Edoxaban} \\\\\n\\hline From & To & Recommendation \\\\\n\\hline Edoxaban & VKA & \\begin{tabular}{l}\nDuring the transition from Edoxaban to VKA, continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. \\\\\nOral option: \\\\\n- For subjects currently on a 60 mg once-daily dose, administer an Edoxaban dose of 30 mg once-daily together with an appropriate VKA dose. \\\\\n- For subjects currently on a 30 mg dose once-daily (for one or more of the following factors: moderate to severe renal impairment ( \\(CrCL =15\\) to \\(\\leq 50 mL / min\\) ), low body weight, or use with certain\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 5.2: Transitioning from Edoxaban at EOT}\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|c|}{Switching from Edoxaban} \\\\\n\\hline From & To & Recommendation \\\\\n\\hline Edoxaban & VKA & \\begin{tabular}{l}\nDuring the transition from Edoxaban to VKA, continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. \\\\\nOral option: \\\\\n- For subjects currently on a 60 mg once-daily dose, administer an Edoxaban dose of 30 mg once-daily together with an appropriate VKA dose. \\\\\n- For subjects currently on a 30 mg dose once-daily (for one or more of the following factors: moderate to severe renal impairment ( \\(CrCL =15\\) to \\(\\leq 50 mL / min\\) ), low body weight, or use with certain\n\\end{tabular} 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the transition from Edoxaban to VKA, continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. \\\\\nOral option: \\\\\n- For subjects currently on a 60 mg once-daily dose, administer an Edoxaban dose of 30 mg once-daily together with an appropriate VKA dose. \\\\\n- For subjects currently on a 30 mg dose once-daily (for one or more of the following factors: moderate to severe renal impairment ( \\(CrCL =15\\) to \\(\\leq 50 mL / min\\) ), low body weight, or use with certain\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nDuring the transition from Edoxaban to VKA, continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. \\\\\nOral option: \\\\\n- For subjects currently on a 60 mg once-daily dose, administer an Edoxaban dose of 30 mg once-daily together with an appropriate VKA dose. \\\\\n- For subjects currently on a 30 mg dose once-daily (for one or more of the following factors: moderate to severe renal impairment ( \\(CrCL =15\\) to \\(\\leq 50 mL / min\\) ), low body weight, or use with certain\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.8449344635009766,"confidence_rate":0.9997887813032916},{"cnt":[[733,2046],[1678,2046],[1678,2087],[733,2087]],"region":{"top_left_x":733,"top_left_y":2046,"width":945,"height":42},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce27f89a1c264fcc9865aebb60022f3e","type":"text","conversion_output":false,"parent_id":"b09d44667d7e40978c7c09b0daa376d1","text":"During the transition from Edoxaban to VKA, continuous adequate","text_display":"During the transition from Edoxaban to VKA, continuous 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\\multicolumn{3}{|c|}{Switching from Edoxaban} \\\\\n\\hline From & To & Recommendation \\\\\n\\hline \\multirow{2}{*}{} & \\multirow{2}{*}{} & \\begin{tabular}{l}\nP-gp inhibitors), administer an Edoxaban dose of 15 mg once-daily together with an appropriate VKA dose. Edoxaban 15 mg oncedaily is not indicated as monotherapy, as it may result in decreased efficacy. It is only indicated in the process of switching from Edoxaban 30 mg once-daily to VKA, together with an appropriate VKA dose. \\\\\nSubjects should not take a loading dose of VKA in order to promptly achieve a stable INR of 2.0 to 3.0 (numbers inclusive) [Japan: 1.6-2.6 in subjects aged \\(\\geq 70\\) (numbers inclusive)]. It is recommended to take into account the maintenance dose of VKA if the subject was previously taking a VKA or to use valid INR driven VKA treatment algorithm, in accordance with local practice. \\\\\nOnce an INR \\(\\geq 2.0\\) is achieved [Japan: \\(\\geq 1.6\\) in subjects aged \\(\\geq 70\\) ], Edoxaban should be discontinued. Most subjects ( \\(85 \\%\\) ) should be able to achieve an INR \\(\\geq 2.0\\) [Japan: 1.6 in subjects aged \\(\\geq 70\\) (numbers inclusive)] within 14 days of concomitant administration of Edoxaban and VKA. After 14 days it is recommended that Edoxaban is discontinued and the VKA continued to be titrated to achieve an INR of 2.0-3.0 (numbers inclusive) [Japan: 1.6-2.6 in subjects aged \\(\\geq 70\\) (numbers inclusive)]. It is recommended that during the first 14 days of concomitant therapy the INR is measured at least three times just prior to taking the daily dose of Edoxaban to minimize the influence of Edoxaban on INR measurements. Concomitant Edoxaban and VKA can increase the INR post Edoxaban dose by up to \\(46 \\%\\).\n\\end{tabular} \\\\\n\\hline & & \\begin{tabular}{l}\nParenteral option: \\\\\nDiscontinue Edoxaban and administer a parenteral anticoagulant and VKA at the time of the next scheduled Edoxaban dose. Once a stable INR of \\(\\geq 2.0\\) is achieved [Japan: \\(\\geq 1.6\\) in subjects aged \\(\\geq 70\\) ], the parenteral anticoagulant should be discontinued and the VKA continued.\n\\end{tabular} \\\\\n\\hline Edoxaban & Other nonVKA OAC drugs & Discontinue Edoxaban and start the non-VKA anticoagulant at the time of the next scheduled dose of Edoxaban. \\\\\n\\hline Edoxaban & Parenteral anticoagulants & These agents should not be administered simultaneously. Discontinue Edoxaban and start the parenteral anticoagulant at the time of the next scheduled dose of Edoxaban. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{3}{|c|}{Switching from Edoxaban} \\\\\n\\hline From & To & Recommendation \\\\\n\\hline \\multirow{2}{*}{} & \\multirow{2}{*}{} & \\begin{tabular}{l}\nP-gp inhibitors), administer an Edoxaban dose of 15 mg once-daily together with an appropriate VKA dose. Edoxaban 15 mg oncedaily is not indicated as monotherapy, as it may result in decreased efficacy. It is only indicated in the process of switching from Edoxaban 30 mg once-daily to VKA, together with an appropriate VKA dose. \\\\\nSubjects should not take a loading dose of VKA in order to promptly achieve a stable INR of 2.0 to 3.0 (numbers inclusive) [Japan: 1.6-2.6 in subjects aged \\(\\geq 70\\) (numbers inclusive)]. It is recommended to take into account the maintenance dose of VKA if the subject was previously taking a VKA or to use valid INR driven VKA treatment algorithm, in accordance with local practice. \\\\\nOnce an INR \\(\\geq 2.0\\) is achieved [Japan: \\(\\geq 1.6\\) in subjects aged \\(\\geq 70\\) ], Edoxaban should be discontinued. Most subjects ( \\(85 \\%\\) ) should be able to achieve an INR \\(\\geq 2.0\\) [Japan: 1.6 in subjects aged \\(\\geq 70\\) (numbers inclusive)] within 14 days of concomitant administration of Edoxaban and VKA. After 14 days it is recommended that Edoxaban is discontinued and the VKA continued to be titrated to achieve an INR of 2.0-3.0 (numbers inclusive) [Japan: 1.6-2.6 in subjects aged \\(\\geq 70\\) (numbers inclusive)]. It is recommended that during the first 14 days of concomitant therapy the INR is measured at least three times just prior to taking the daily dose of Edoxaban to minimize the influence of Edoxaban on INR measurements. Concomitant Edoxaban and VKA can increase the INR post Edoxaban dose by up to \\(46 \\%\\).\n\\end{tabular} \\\\\n\\hline & & \\begin{tabular}{l}\nParenteral option: \\\\\nDiscontinue Edoxaban and administer a parenteral anticoagulant and VKA at the time of the next scheduled Edoxaban dose. Once a stable INR of \\(\\geq 2.0\\) is achieved [Japan: \\(\\geq 1.6\\) in subjects aged \\(\\geq 70\\) ], the parenteral anticoagulant should be discontinued and the VKA continued.\n\\end{tabular} \\\\\n\\hline Edoxaban & Other nonVKA OAC drugs & Discontinue Edoxaban and start the non-VKA anticoagulant at the time of the next scheduled dose of Edoxaban. \\\\\n\\hline Edoxaban & Parenteral anticoagulants & These agents should not be administered simultaneously. Discontinue Edoxaban and start the parenteral anticoagulant at the time of the next scheduled dose of Edoxaban. 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Edoxaban 15 mg oncedaily is not indicated as monotherapy, as it may result in decreased efficacy. It is only indicated in the process of switching from Edoxaban 30 mg once-daily to VKA, together with an appropriate VKA dose. \\\\\nSubjects should not take a loading dose of VKA in order to promptly achieve a stable INR of 2.0 to 3.0 (numbers inclusive) [Japan: 1.6-2.6 in subjects aged \\(\\geq 70\\) (numbers inclusive)]. It is recommended to take into account the maintenance dose of VKA if the subject was previously taking a VKA or to use valid INR driven VKA treatment algorithm, in accordance with local practice. \\\\\nOnce an INR \\(\\geq 2.0\\) is achieved [Japan: \\(\\geq 1.6\\) in subjects aged \\(\\geq 70\\) ], Edoxaban should be discontinued. Most subjects ( \\(85 \\%\\) ) should be able to achieve an INR \\(\\geq 2.0\\) [Japan: 1.6 in subjects aged \\(\\geq 70\\) (numbers inclusive)] within 14 days of concomitant administration of Edoxaban and VKA. 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It is only indicated in the process of switching from","text_display":" efficacy. It is only indicated in the process of switching from","confidence":1,"confidence_rate":1},{"cnt":[[861,539],[1790,539],[1790,578],[861,578]],"region":{"top_left_x":861,"top_left_y":538,"width":930,"height":40},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cd093b0f0c2b4065ac49d72bfdc2c7c3","type":"text","conversion_output":false,"parent_id":"c21d94d518464fa0896e7506d4dd9bf9","text":"Edoxaban 30 mg once-daily to VKA, together with an appropriate","text_display":" Edoxaban 30 mg once-daily to VKA, together with an appropriate","confidence":1,"confidence_rate":1},{"cnt":[[861,580],[1021,580],[1021,612],[861,612]],"region":{"top_left_x":861,"top_left_y":579,"width":161,"height":34},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"375cd18603fe4971be5d69a811816c74","type":"text","conversion_output":false,"parent_id":"c21d94d518464fa0896e7506d4dd9bf9","text":"VKA dose.","text_display":" VKA dose.","confidence":1,"confidence_rate":1},{"cnt":[[735,627],[1812,627],[1812,669],[735,669]],"region":{"top_left_x":735,"top_left_y":627,"width":1077,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0d2f0629501410a8885ac11bb891328","type":"text","conversion_output":false,"parent_id":"c21d94d518464fa0896e7506d4dd9bf9","text":"Subjects should not take a loading dose of VKA in order to promptly achieve","text_display":"\nSubjects should not take a loading dose of VKA in order to promptly achieve","confidence":1,"confidence_rate":1},{"cnt":[[735,669],[1751,669],[1751,712],[735,712]],"region":{"top_left_x":735,"top_left_y":668,"width":1017,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90bf8ec0853346b8a3fb18f8aa861fba","type":"text","conversion_output":false,"parent_id":"c21d94d518464fa0896e7506d4dd9bf9","text":"a stable INR of 2.0 to 3.0 (numbers inclusive) [Japan: 1.6-2.6 in subjects","text_display":" a stable INR of 2.0 to 3.0 (numbers inclusive) [Japan: 1.6-2.6 in subjects","confidence":0.99755859375,"confidence_rate":0.9999712428682969},{"cnt":[[735,710],[1777,710],[1777,751],[735,751]],"region":{"top_left_x":735,"top_left_y":709,"width":1043,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae6383dd16044f6f88e1735c3012f5cb","type":"text","conversion_output":false,"parent_id":"c21d94d518464fa0896e7506d4dd9bf9","text":"aged \\(\\geq 70\\) (numbers inclusive)]. It is recommended to take into account the","text_display":" aged \\(\\geq 70\\) (numbers inclusive)]. 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measured.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nIf the INR measured on the day of randomization is: \\\\\n- \\(\\leq 2.5\\), start study VKA \\\\\n- >2.5, the Investigator or designee must recheck at a later time; start study VKA when the INR is \\(\\leq\\) 2.5: document the INR value and the date it was measured.\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.8435890674591064,"confidence_rate":0.9994171869897117},{"cnt":[[1025,757],[1651,757],[1651,790],[1025,790]],"region":{"top_left_x":1025,"top_left_y":757,"width":627,"height":33},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"acac51fb57c64f3bbe77f0174c9d52d8","type":"text","conversion_output":false,"parent_id":"da59fe18de0f4d6f9c039b6d57a3b6a7","text":"If the INR measured on the day of randomization is:","text_display":"If the INR measured on the day of randomization 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INR value and the date it was","confidence":0.9736328125,"confidence_rate":0.9994862659366026},{"cnt":[[1132,930],[1264,930],[1264,963],[1132,963]],"region":{"top_left_x":1131,"top_left_y":930,"width":133,"height":33},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fff9398fd074c85a5082ddfbcd36c50","type":"text","conversion_output":false,"parent_id":"da59fe18de0f4d6f9c039b6d57a3b6a7","text":"measured.","text_display":" 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apixaban\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[343,1034],[692,1034],[692,1069],[343,1069]],"region":{"top_left_x":343,"top_left_y":1034,"width":349,"height":36},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2602430aabf4719bb3a838aa5ce12bf","type":"text","conversion_output":false,"parent_id":"2f87675c7b8a4fcf9557b30aed25c7cd","text":"Other non-VKA OAC drugs","text_display":"Other non-VKA OAC drugs","confidence":1,"confidence_rate":1},{"cnt":[[339,1069],[523,1069],[523,1106],[339,1106]],"region":{"top_left_x":338,"top_left_y":1069,"width":186,"height":37},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92a29f8abbd64d4398304a9affee086a","type":"text","conversion_output":false,"parent_id":"2f87675c7b8a4fcf9557b30aed25c7cd","text":"- dabigatran","text_display":"\n- 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apixaban","confidence":1,"confidence_rate":1},{"cnt":[[789,1086],[939,1086],[939,1128],[789,1128]],"region":{"top_left_x":789,"top_left_y":1086,"width":150,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27b9ae94fdb5428aa4a28dccac3ea8c7","type":"simple_cell","conversion_output":false,"parent_id":"193527ef9d944e649cabbf1dbe3fd475","text":"Study VKA","text_display":"Study VKA","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1023,1032],[1714,1032],[1714,1180],[1023,1180]],"region":{"top_left_x":1023,"top_left_y":1032,"width":692,"height":148},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28798b842de6497e8570838ecf355a63","type":"complex_cell","conversion_output":false,"parent_id":"193527ef9d944e649cabbf1dbe3fd475","children_ids":["381cc0fa9a99454bac7a881ddc1bb1b5","5747c03011924d21865dcc49bee3bf79","7ffb847be76d477caa3da7d2a4bfa3ca","22dc1e47085248eb952965381ba98b39"],"text":"Ascertain adequate anticoagulation until an INR \\(\\geq 2.0\\) is reached and then continue with study VKA only. Follow local label of country-selected VKA and label of NOAC being stopped for further guidance.","text_display":"Ascertain adequate anticoagulation until an INR \\(\\geq 2.0\\) is reached and then continue with study VKA only. Follow local label of country-selected VKA and label of NOAC being stopped for further guidance.","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9921875,"confidence_rate":0.9999688767642545},{"cnt":[[1028,1034],[1697,1034],[1697,1071],[1028,1071]],"region":{"top_left_x":1027,"top_left_y":1034,"width":670,"height":38},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"381cc0fa9a99454bac7a881ddc1bb1b5","type":"text","conversion_output":false,"parent_id":"28798b842de6497e8570838ecf355a63","text":"Ascertain adequate anticoagulation until an INR \\(\\geq 2.0\\) is","text_display":"Ascertain adequate anticoagulation until an INR \\(\\geq 2.0\\) is","confidence":0.9921875,"confidence_rate":0.9998755128688323},{"cnt":[[1028,1069],[1710,1069],[1710,1106],[1028,1106]],"region":{"top_left_x":1027,"top_left_y":1069,"width":683,"height":37},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5747c03011924d21865dcc49bee3bf79","type":"text","conversion_output":false,"parent_id":"28798b842de6497e8570838ecf355a63","text":"reached and then continue with study VKA only. Follow","text_display":" reached and then continue with study VKA only. Follow","confidence":1,"confidence_rate":1},{"cnt":[[1028,1104],[1708,1104],[1708,1141],[1028,1141]],"region":{"top_left_x":1027,"top_left_y":1103,"width":681,"height":38},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ffb847be76d477caa3da7d2a4bfa3ca","type":"text","conversion_output":false,"parent_id":"28798b842de6497e8570838ecf355a63","text":"local label of country-selected VKA and label of NOAC","text_display":" local label of country-selected VKA and label of NOAC","confidence":1,"confidence_rate":1},{"cnt":[[1028,1138],[1454,1138],[1454,1175],[1028,1175]],"region":{"top_left_x":1027,"top_left_y":1138,"width":428,"height":38},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22dc1e47085248eb952965381ba98b39","type":"text","conversion_output":false,"parent_id":"28798b842de6497e8570838ecf355a63","text":"being stopped for further guidance.","text_display":" being stopped for further guidance.","confidence":1,"confidence_rate":1},{"cnt":[[365,1316],[675,1316],[675,1353],[365,1353]],"region":{"top_left_x":364,"top_left_y":1315,"width":311,"height":38},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9092dfd8d3a0497eb7c249b8381ab72a","type":"simple_cell","conversion_output":false,"parent_id":"193527ef9d944e649cabbf1dbe3fd475","text":"Parenteral anticoagulants","text_display":"Parenteral anticoagulants","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[789,1312],[939,1312],[939,1353],[789,1353]],"region":{"top_left_x":789,"top_left_y":1311,"width":150,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"767fb5d62a4b4b5196ce303d4a6d8bb3","type":"simple_cell","conversion_output":false,"parent_id":"193527ef9d944e649cabbf1dbe3fd475","text":"Study VKA","text_display":"Study VKA","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1023,1225],[1727,1225],[1727,1439],[1023,1439]],"region":{"top_left_x":1023,"top_left_y":1225,"width":705,"height":215},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"808618d3e8fd4d99b68fe95d307ee26e","type":"complex_cell","conversion_output":false,"parent_id":"193527ef9d944e649cabbf1dbe3fd475","children_ids":["5a9f6b798b9d40d8924977e6237bbded","f3fabe93f1104995878c64dc47f36bc9","45b706ac63824ac483336bc915fa29d8","8e76c2fe5f1e461cbd7d5ef1c538804a","7c07f320916b4ba186d097df76c9ee67","dcceace8e85e4175843a4200fc24d8f0"],"text":"For subjects not previously on VKA, bridging with parenteral anticoagulation is permissible, but not recommended. For initiation of VKA therapy and related bridging with parenteral anticoagulation, follow locally established guidelines and local approved label (prescribing information) from the VKA manufacturer.","text_display":"For subjects not previously on VKA, bridging with parenteral anticoagulation is permissible, but not recommended. For initiation of VKA therapy and related bridging with parenteral anticoagulation, follow locally established guidelines and local approved label (prescribing information) from the VKA manufacturer.","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999985719293878},{"cnt":[[1030,1229],[1645,1229],[1645,1266],[1030,1266]],"region":{"top_left_x":1029,"top_left_y":1229,"width":616,"height":38},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a9f6b798b9d40d8924977e6237bbded","type":"text","conversion_output":false,"parent_id":"808618d3e8fd4d99b68fe95d307ee26e","text":"For subjects not previously on VKA, bridging with","text_display":"For subjects not previously on VKA, bridging with","confidence":1,"confidence_rate":1},{"cnt":[[1030,1264],[1614,1264],[1614,1301],[1030,1301]],"region":{"top_left_x":1029,"top_left_y":1263,"width":586,"height":38},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3fabe93f1104995878c64dc47f36bc9","type":"text","conversion_output":false,"parent_id":"808618d3e8fd4d99b68fe95d307ee26e","text":"parenteral anticoagulation is permissible, but not","text_display":" parenteral anticoagulation is permissible, but not","confidence":1,"confidence_rate":1},{"cnt":[[1030,1299],[1723,1299],[1723,1335],[1030,1335]],"region":{"top_left_x":1029,"top_left_y":1298,"width":694,"height":38},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"45b706ac63824ac483336bc915fa29d8","type":"text","conversion_output":false,"parent_id":"808618d3e8fd4d99b68fe95d307ee26e","text":"recommended. For initiation of VKA therapy and related","text_display":" recommended. For initiation of VKA therapy and related","confidence":1,"confidence_rate":1},{"cnt":[[1032,1329],[1697,1329],[1697,1370],[1032,1370]],"region":{"top_left_x":1031,"top_left_y":1328,"width":666,"height":43},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8e76c2fe5f1e461cbd7d5ef1c538804a","type":"text","conversion_output":false,"parent_id":"808618d3e8fd4d99b68fe95d307ee26e","text":"bridging with parenteral anticoagulation, follow locally","text_display":" bridging with parenteral anticoagulation, follow locally","confidence":1,"confidence_rate":1},{"cnt":[[1032,1364],[1597,1364],[1597,1405],[1032,1405]],"region":{"top_left_x":1031,"top_left_y":1363,"width":567,"height":42},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c07f320916b4ba186d097df76c9ee67","type":"text","conversion_output":false,"parent_id":"808618d3e8fd4d99b68fe95d307ee26e","text":"established guidelines and local approved label","text_display":" established guidelines and local approved label","confidence":1,"confidence_rate":1},{"cnt":[[1030,1398],[1692,1398],[1692,1439],[1030,1439]],"region":{"top_left_x":1029,"top_left_y":1398,"width":664,"height":42},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dcceace8e85e4175843a4200fc24d8f0","type":"text","conversion_output":false,"parent_id":"808618d3e8fd4d99b68fe95d307ee26e","text":"(prescribing information) from the VKA manufacturer.","text_display":" (prescribing information) from the VKA manufacturer.","confidence":0.99951171875,"confidence_rate":0.9999914316069175},{"cnt":[[309,1487],[1755,1487],[1755,1528],[309,1528]],"region":{"top_left_x":309,"top_left_y":1486,"width":1447,"height":42},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8c649917218843599ad0441622b24808","type":"text","conversion_output":true,"text":"\\(INR =\\) international normalized ratio; NOAC = non- oral anticoagulant(s); OAC = oral anticoagulant(s);","text_display":"\n\\(INR =\\) international normalized ratio; NOAC = non- oral anticoagulant(s); OAC = oral anticoagulant(s);","confidence":0.5244293692483503,"confidence_rate":0.9939859653356459},{"cnt":[[335,1525],[746,1525],[746,1566],[335,1566]],"region":{"top_left_x":335,"top_left_y":1525,"width":411,"height":42},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"edbaf668ea2c4909a8f5f9e681e24c5f","type":"text","conversion_output":true,"text":"VKA \\(=\\) vitamin K antagonist","text_display":" VKA \\(=\\) vitamin K antagonist","confidence":0.8413858413696289,"confidence_rate":0.9949333222087581},{"cnt":[[305,1607],[1210,1607],[1210,1661],[305,1661]],"region":{"top_left_x":305,"top_left_y":1607,"width":905,"height":54},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eebf8abae76a40c4ad070afc4f98efa0","type":"section_header","conversion_output":false,"children_ids":["51e1de75b52e4d02b6ff80f60c966539"],"text":"","text_display":""},{"cnt":[[309,1611],[1205,1611],[1205,1656],[309,1656]],"region":{"top_left_x":309,"top_left_y":1611,"width":897,"height":46},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51e1de75b52e4d02b6ff80f60c966539","type":"text","conversion_output":true,"parent_id":"eebf8abae76a40c4ad070afc4f98efa0","text":"5.2.1.2.2. Transitioning from Study VKA at EOT","text_display":"\n\n\\subsection*{5.2.1.2.2. 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Subject Withdrawal/Discontinuation","text_display":"\n\n\\subsection*{5.8. Subject Withdrawal/Discontinuation}","confidence":0.7705078125,"confidence_rate":0.9940923942798903},{"cnt":[[309,584],[1766,584],[1766,629],[309,629]],"region":{"top_left_x":309,"top_left_y":584,"width":1458,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5303293c3eb24dcaa203ae0e5ffe97dc","type":"text","conversion_output":true,"text":"The intended duration of the two treatment regimens is up to 36 months. Subjects must","text_display":"\n\nThe intended duration of the two treatment regimens is up to 36 months. Subjects must","confidence":0.9892780780792236,"confidence_rate":0.9998840947183879},{"cnt":[[309,632],[1351,632],[1351,681],[309,681]],"region":{"top_left_x":309,"top_left_y":631,"width":1043,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0719f19c357a4595a9b41e9dd2a393a8","type":"text","conversion_output":true,"text":"stay on the assigned OAC-based regimen as much as possible.","text_display":" stay on the assigned OAC-based regimen as much as possible.","confidence":1,"confidence_rate":1},{"cnt":[[309,703],[1811,703],[1811,750],[309,750]],"region":{"top_left_x":309,"top_left_y":702,"width":1503,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4d0e79c40334eff8a338d6f4dc40e9a","type":"text","conversion_output":true,"text":"Discontinuation of the assigned regimen is mandatory if the CrCL falls below \\(15 mL / min\\)","text_display":"\n\nDiscontinuation of the assigned regimen is mandatory if the CrCL falls below \\(15 mL / min\\)","confidence":0.9853515625,"confidence_rate":0.9998446774822562},{"cnt":[[309,752],[1704,752],[1704,797],[309,797]],"region":{"top_left_x":309,"top_left_y":751,"width":1395,"height":47},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d19413220c7a49668290e4058d85900b","type":"text","conversion_output":true,"text":"on two consecutive occasions or if subject is placed on dialysis. 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The timing of the repeat","text_display":" condition that caused the worsening renal function resolves. 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During each interruption of anticoagulant or antiplatelet therapy, subjects are","confidence":1,"confidence_rate":1},{"cnt":[[309,1568],[1637,1568],[1637,1618],[309,1618]],"region":{"top_left_x":309,"top_left_y":1568,"width":1329,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab354d94c6ef4ac4951ae8006d4c148f","type":"text","conversion_output":true,"text":"evaluated to determine whether the subject can safely resume the study drug. A","text_display":" evaluated to determine whether the subject can safely resume the study drug. 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Clinical follow-up before the end of the study is only","text_display":" in the antithrombotic regimen. 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For information on","text_display":" retrieved from the subject to avoid drug administration errors. 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A procedure is not an AE or SAE, but the reason for the procedure may","text_display":"\nhospitalization). 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treatment requiring hospitalization","confidence":1,"confidence_rate":1},{"cnt":[[309,421],[1729,421],[1729,466],[309,466]],"region":{"top_left_x":309,"top_left_y":421,"width":1421,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee1e3d06622c48b4ac5fba1c303d3a6c","type":"text","conversion_output":true,"text":"for pre-existing conditions which do not worsen in severity should not be reported as","text_display":" for pre-existing conditions which do not worsen in severity should not be reported as","confidence":1,"confidence_rate":1},{"cnt":[[309,468],[986,468],[986,513],[309,513]],"region":{"top_left_x":309,"top_left_y":468,"width":678,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56361c6ba6a54a04aa62a6039830f7ab","type":"text","conversion_output":true,"text":"SAEs (see Section 9.3.4 for definitions).","text_display":" SAEs (see Section 9.3.4 for 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In case of unresolved adverse events including significant","confidence":1,"confidence_rate":1},{"cnt":[[309,920],[1792,920],[1792,965],[309,965]],"region":{"top_left_x":309,"top_left_y":919,"width":1483,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ee52456810e4403885ca7ca314e5983","type":"text","conversion_output":true,"text":"abnormal laboratory values at the end of study assessment, these events will be followed","text_display":" abnormal laboratory values at the end of study assessment, these events will be followed","confidence":1,"confidence_rate":1},{"cnt":[[309,967],[1356,967],[1356,1016],[309,1016]],"region":{"top_left_x":309,"top_left_y":966,"width":1047,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53a41f9457d847f08cf1dd33b7a48846","type":"text","conversion_output":true,"text":"up until resolution or until they become clinically not relevant.","text_display":" up until 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(e.g., seasonal allergy without acute complaints).","confidence":1,"confidence_rate":1},{"cnt":[[309,1369],[1755,1369],[1755,1416],[309,1416]],"region":{"top_left_x":309,"top_left_y":1368,"width":1447,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af10565bbbfe47e2a7e4a800bf9a4658","type":"text","conversion_output":true,"text":"Conditions that started before signing of informed consent and for which symptoms or","text_display":"\n\nConditions that started before signing of informed consent and for which symptoms or","confidence":1,"confidence_rate":1},{"cnt":[[309,1418],[1699,1418],[1699,1463],[309,1463]],"region":{"top_left_x":309,"top_left_y":1417,"width":1391,"height":47},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcd07d545f544cf0b5bf4aaf0483c460","type":"text","conversion_output":true,"text":"treatment are present after signing of informed consent, at unchanged intensity, are","text_display":" treatment are present after signing of informed consent, at unchanged intensity, are","confidence":1,"confidence_rate":1},{"cnt":[[309,1465],[1199,1465],[1199,1515],[309,1515]],"region":{"top_left_x":309,"top_left_y":1465,"width":890,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4644e73e82f542fbbdcb98bf20877cbb","type":"text","conversion_output":true,"text":"recorded as medical history (e.g., allergic pollinosis).","text_display":" recorded as medical history (e.g., allergic pollinosis).","confidence":1,"confidence_rate":1},{"cnt":[[309,1534],[1772,1534],[1772,1583],[309,1583]],"region":{"top_left_x":309,"top_left_y":1533,"width":1464,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3aced819a3c24339addd722ae20e01fb","type":"text","conversion_output":true,"text":"Conditions that started or deteriorated after the first dose of drug will be documented as","text_display":"\n\nConditions that started or deteriorated after the first dose of drug will be documented as","confidence":1,"confidence_rate":1},{"cnt":[[309,1586],[1162,1586],[1162,1626],[309,1626]],"region":{"top_left_x":309,"top_left_y":1585,"width":854,"height":42},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87e04477b25843ee97ea7f7587669974","type":"text","conversion_output":true,"text":"adverse events; these include intercurrent illnesses.","text_display":" adverse events; these include intercurrent 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Bleeding events that do not require medical attention will be classified","text_display":" Section 17.1.1). Bleeding events that do not require medical attention will be classified","confidence":1,"confidence_rate":1},{"cnt":[[309,1955],[1068,1955],[1068,2004],[309,2004]],"region":{"top_left_x":309,"top_left_y":1955,"width":759,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e250613a900433f83e735957d58307e","type":"text","conversion_output":true,"text":"as minor bleeding without CEC adjudication.","text_display":" as minor bleeding without CEC adjudication.","confidence":1,"confidence_rate":1},{"cnt":[[309,2024],[1622,2024],[1622,2073],[309,2073]],"region":{"top_left_x":309,"top_left_y":2023,"width":1314,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"432a3a948a20455e928aa286165d4a26","type":"text","conversion_output":true,"text":"The CEC will require all available details about the bleeding event and related","text_display":"\n\nThe CEC will require all available details about the bleeding event and related","confidence":1,"confidence_rate":1},{"cnt":[[309,2075],[1785,2075],[1785,2121],[309,2121]],"region":{"top_left_x":309,"top_left_y":2075,"width":1477,"height":46},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"540c5bedbfb94c1abe50ad4c68e53643","type":"text","conversion_output":true,"text":"information to allow successful objective adjudication of the event. 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adjudicated","text_display":" periods may be considered to evaluate the robustness of the main analyses on adjudicated","confidence":1,"confidence_rate":1},{"cnt":[[309,1418],[1708,1418],[1708,1465],[309,1465]],"region":{"top_left_x":309,"top_left_y":1417,"width":1400,"height":49},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"217bb0a4852f429d803fa7b9201d66c1","type":"text","conversion_output":true,"text":"safety or efficacy endpoints. 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Interruptions and permanent discontinuations (see Section 5.8) will be","text_display":" analysis sets. 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An AE that","confidence":1,"confidence_rate":1},{"cnt":[[309,1435],[1790,1435],[1790,1482],[309,1482]],"region":{"top_left_x":309,"top_left_y":1435,"width":1481,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63057ca3b6be42d7b2f38a5e528736e7","type":"text","conversion_output":true,"text":"occurs more than 30 days after the date of the last dose of the assigned study medication","text_display":" occurs more than 30 days after the date of the last dose of the assigned study medication","confidence":1,"confidence_rate":1},{"cnt":[[309,1487],[982,1487],[982,1532],[309,1532]],"region":{"top_left_x":309,"top_left_y":1486,"width":673,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"413369d45e9545719534c334ed7096c4","type":"text","conversion_output":true,"text":"regimen will not be counted as a TEAE.","text_display":" regimen will not be counted as a TEAE.","confidence":1,"confidence_rate":1},{"cnt":[[309,1555],[1665,1555],[1665,1601],[309,1601]],"region":{"top_left_x":309,"top_left_y":1555,"width":1357,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c05d6c20f354e7c92328e9bbafa6dab","type":"text","conversion_output":true,"text":"TEAEs will be summarized by treatment group. The incidence of TEAEs will be","text_display":"\n\nTEAEs will be summarized by treatment group. The incidence of TEAEs will be","confidence":1,"confidence_rate":1},{"cnt":[[309,1603],[1712,1603],[1712,1648],[309,1648]],"region":{"top_left_x":309,"top_left_y":1602,"width":1404,"height":46},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cc7c7ff263e4502b9ea4f6dd5a6f8ff","type":"text","conversion_output":true,"text":"presented by treatment group, by relationship to the assigned study regimen, and by","text_display":" presented by treatment group, by relationship to the assigned study regimen, and by","confidence":1,"confidence_rate":1},{"cnt":[[309,1650],[1760,1650],[1760,1695],[309,1695]],"region":{"top_left_x":309,"top_left_y":1650,"width":1451,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd808055a6094c52ac9e88eb0f56b4f0","type":"text","conversion_output":true,"text":"severity. If more than one AE is coded to the same preferred term for the same subject,","text_display":" severity. If more than one AE is coded to the same preferred term for the same subject,","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[309,1697],[1760,1697],[1760,1742],[309,1742]],"region":{"top_left_x":309,"top_left_y":1697,"width":1451,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf9c7aff0a2a458a98bc721e4490db37","type":"text","conversion_output":true,"text":"the subject will be counted only once for that preferred term using the greatest severity","text_display":" the subject will be counted only once for that preferred term using the greatest severity","confidence":1,"confidence_rate":1},{"cnt":[[309,1745],[1646,1745],[1646,1790],[309,1790]],"region":{"top_left_x":309,"top_left_y":1744,"width":1337,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf9c71ab469b4d1591d596995ef78060","type":"text","conversion_output":true,"text":"and strictest causality for the summarization by severity and causal relationship.","text_display":" and strictest causality for the summarization by severity and causal relationship.","confidence":0.99658203125,"confidence_rate":0.9999606464829958},{"cnt":[[309,1792],[1704,1792],[1704,1841],[309,1841]],"region":{"top_left_x":309,"top_left_y":1791,"width":1395,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3105e9ab1144000a37333118b6345fc","type":"text","conversion_output":true,"text":"Frequent TEAE (reported by at least \\(5 \\%\\) of subjects in any treatment group) will be","text_display":" Frequent TEAE (reported by at least \\(5 \\%\\) of subjects in any treatment group) will be","confidence":0.99658203125,"confidence_rate":0.9999619582419443},{"cnt":[[309,1841],[834,1841],[834,1888],[309,1888]],"region":{"top_left_x":309,"top_left_y":1841,"width":525,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa2a2926ef9849cc97ca07a02d00f176","type":"text","conversion_output":true,"text":"summarized by regimen group.","text_display":" summarized by regimen group.","confidence":1,"confidence_rate":1},{"cnt":[[309,1912],[1669,1912],[1669,1957],[309,1957]],"region":{"top_left_x":309,"top_left_y":1912,"width":1361,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2241ccdb12c542ad8a4394c73faf7afa","type":"text","conversion_output":true,"text":"The incidence of death, SAEs, drug-related SAEs, and AEs leading to permanent","text_display":"\n\nThe incidence of death, SAEs, drug-related SAEs, and AEs leading to permanent","confidence":1,"confidence_rate":1},{"cnt":[[309,1959],[1790,1959],[1790,2004],[309,2004]],"region":{"top_left_x":309,"top_left_y":1959,"width":1481,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"137aa01613a84bf982539599092e08b9","type":"text","conversion_output":true,"text":"discontinuation of the assigned study regimen will be summarized. All AEs meeting the","text_display":" discontinuation of the assigned study regimen will be summarized. All AEs meeting the","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[309,2007],[1775,2007],[1775,2054],[309,2054]],"region":{"top_left_x":309,"top_left_y":2006,"width":1466,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59bc36b6a908462cab5c889e1cd65424","type":"text","conversion_output":true,"text":"criteria defined in Section 9.3.4 will be included in a data listing and a listing to display","text_display":" criteria defined in Section 9.3.4 will be included in a data listing and a listing to display","confidence":1,"confidence_rate":1},{"cnt":[[309,2058],[1033,2058],[1033,2103],[309,2103]],"region":{"top_left_x":309,"top_left_y":2058,"width":725,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d3cb89647594630861690376cf0ed33","type":"text","conversion_output":true,"text":"the coding of AEs will be prepared as well.","text_display":" the coding of AEs will be prepared as well.","confidence":1,"confidence_rate":1},{"cnt":[[309,2144],[1231,2144],[1231,2194],[309,2194]],"region":{"top_left_x":309,"top_left_y":2144,"width":923,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72dcdb9ca789438c8467159a81817d95","type":"section_header","conversion_output":false,"children_ids":["fcb97970b016433a904d5a18b2050fef"],"text":"","text_display":""},{"cnt":[[314,2148],[1231,2148],[1231,2194],[314,2194]],"region":{"top_left_x":313,"top_left_y":2148,"width":919,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcb97970b016433a904d5a18b2050fef","type":"text","conversion_output":true,"parent_id":"72dcdb9ca789438c8467159a81817d95","text":"11.5.2 Clinical Laboratory Evaluation Analyses","text_display":"\n\n\\subsection*{11.5.2 Clinical Laboratory Evaluation Analyses}","confidence":0.671875,"confidence_rate":0.9922326179868088},{"cnt":[[309,2213],[1626,2213],[1626,2260],[309,2260]],"region":{"top_left_x":309,"top_left_y":2212,"width":1318,"height":49},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b6da8ca2cfc470487b6e6b19335006d","type":"text","conversion_output":true,"text":"The clinical laboratory evaluations for each scheduled test will be summarized","text_display":"\n\nThe clinical laboratory evaluations for each scheduled test will be summarized","confidence":1,"confidence_rate":1},{"cnt":[[309,2264],[1714,2264],[1714,2310],[309,2310]],"region":{"top_left_x":309,"top_left_y":2264,"width":1406,"height":46},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2070770076c142ab807a94a404def0ef","type":"text","conversion_output":true,"text":"descriptively by treatment regimen and visit (including changes from baseline). 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Visit Number & & 1 & 2* & 3* & 4* & 5* & 6* & 7* & 8* & 9* & 10 \\\\\n\\hline Visit timing & Screening & Baseline/randomization (DAY 1) & \\(3 ~ M\\) ± 14d & 6 M \\(\\pm 1 4 d\\) & \\(1 2 M \\pm 14 d\\) & \\(1 8 M\\) ± 14d & \\(2 4 M \\pm 1 4 d\\) & 30M \\(\\pm 14 d\\) & EOT \\(^{ l , m } 3 6 M \\pm 1 4 d\\) & Post treatment Follow-up 1 M post EOT ± 7d & Follow-up contact (every \\(6 \\pm 1\\) months after EOT) \\({ }^{\\text {p }}\\) \\\\\n\\hline Study informed consent \\({ }^{ a }\\) & \\(x\\) & & & & & & & & & & \\\\\n\\hline Inclusion/Exclusion Criteria & \\(x\\) & & & & & & & & & & \\\\\n\\hline Record EuroSCORE 1 and 2, STS elements and CHAD and HAS-Bleed scores in eCRF & & \\(x\\) & & & & & & & & & \\\\\n\\hline Check local lab results \\({ }^{\\text {b }}\\) & \\(x\\) & & & & & & & & & & \\\\\n\\hline Demographic information & \\(x\\) & & & & & & & & & & \\\\\n\\hline Medical/surgical history (including bleeding and for the past 30 days, medication history) & \\(x\\) & \\(x\\) 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\\(AE =\\) adverse event; \\(CBC =\\) complete blood count; \\(CrCL =\\) creatinine clearance; \\(CRO =\\) clinical research organization; \\(CT =\\) computer","text_display":"\n\nAbbreviations: \\(AE =\\) adverse event; \\(CBC =\\) complete blood count; \\(CrCL =\\) creatinine clearance; \\(CRO =\\) clinical research organization; \\(CT =\\) computer","confidence":0.9771647257430777,"confidence_rate":0.9998664826857626},{"cnt":[[331,1588],[2383,1588],[2383,1629],[331,1629]],"region":{"top_left_x":330,"top_left_y":1587,"width":2053,"height":42},"line":153,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ddfe7f0952394b2f8bde055e45bdc118","type":"text","conversion_output":true,"text":"tomography; d = day(s); ECG = electrocardiogram; echo = echocardiogram; eCRF = electronic case report form; EQ-5D-5L = EuroQuality of Life","text_display":" tomography; d = day(s); ECG = electrocardiogram; echo = echocardiogram; eCRF = electronic case report form; EQ-5D-5L = EuroQuality of Life","confidence":0.98974609375,"confidence_rate":0.9999279267952486},{"cnt":[[335,1629],[2271,1629],[2271,1669],[335,1669]],"region":{"top_left_x":335,"top_left_y":1628,"width":1936,"height":42},"line":154,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bf65c398bb8b45b4b0d3fb67963a261c","type":"text","conversion_output":true,"text":"(EQ-5D-5L) Questionnaire; EOT = end of treatment; INR = international normalized ratio; IXRS = interactive web/voice response system;","text_display":" (EQ-5D-5L) Questionnaire; EOT = end of treatment; INR = international normalized ratio; IXRS = interactive web/voice response system;","confidence":0.9226561467831025,"confidence_rate":0.9994168465306564},{"cnt":[[335,1667],[2322,1667],[2322,1708],[335,1708]],"region":{"top_left_x":335,"top_left_y":1667,"width":1988,"height":42},"line":155,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"25709f79046d41a5b06ecee56b5c286f","type":"text","conversion_output":true,"text":"\\(M =\\) month(s); NA \\(=\\) not applicable; PACT-Q \\(=\\) Perception of Anticoagulant Treatment Questionnaire; OAC \\(=\\) oral anticoagulant; OAP \\(=\\) oral","text_display":" \\(M =\\) month(s); NA \\(=\\) not applicable; PACT-Q \\(=\\) Perception of Anticoagulant Treatment Questionnaire; OAC \\(=\\) oral anticoagulant; OAP \\(=\\) oral","confidence":0.3147209065875224,"confidence_rate":0.9923731467955479},{"cnt":[[333,1706],[2400,1706],[2400,1747],[333,1747]],"region":{"top_left_x":333,"top_left_y":1705,"width":2067,"height":42},"line":156,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f865957e39f46b8aa53dab06e58ae36","type":"text","conversion_output":true,"text":"antiplatelet; SAE = serious AE; STS = Society of Thoracic Surgeons; TEE = transesophageal echo; TTE = transthoracic echo; ULN = upper limit of","text_display":" antiplatelet; SAE = serious AE; STS = Society of Thoracic Surgeons; TEE = transesophageal echo; TTE = transthoracic echo; ULN = upper limit of","confidence":0.9800169250271438,"confidence_rate":0.9998626935292277},{"cnt":[[335,1749],[879,1749],[879,1790],[335,1790]],"region":{"top_left_x":335,"top_left_y":1748,"width":544,"height":42},"line":157,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48147c66d4d04643aedbb976ca1ef15b","type":"text","conversion_output":true,"text":"normal; VKA = Vitamin K antagonist.","text_display":" normal; VKA = Vitamin K antagonist.","confidence":0.9680271148681641,"confidence_rate":0.9991879503691448},{"cnt":[[1130,1908],[1613,1908],[1613,1957],[1130,1957]],"region":{"top_left_x":1130,"top_left_y":1907,"width":484,"height":51},"line":158,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cddb0a10f3f4f67871200f7d556f852","type":"page_info","conversion_output":false,"text":"Proprietary and Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1293,1955],[1454,1955],[1454,2004],[1293,2004]],"region":{"top_left_x":1293,"top_left_y":1955,"width":162,"height":50},"line":159,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b710421b327b45a999754d706217c4ff","type":"page_info","conversion_output":false,"text":"Page 105","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"26e08de1-160a-4741-ac91-a7799d6d9159-106","page":106,"lines":[{"cnt":[[54,39],[930,39],[930,73],[54,73]],"region":{"top_left_x":53,"top_left_y":38,"width":878,"height":36},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"cd243a993e494903b50f8e733272f71a","type":"page_info","conversion_output":false,"text":"DocuSign Envelope ID: A990BBB0-071F-4B3E-820D-891DBA7FBEF1","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999844953424807},{"cnt":[[1964,129],[2436,129],[2436,168],[1964,168]],"region":{"top_left_x":1963,"top_left_y":128,"width":474,"height":40},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"935b50b20fc945b2800f45ba5746b43f","type":"page_info","conversion_output":false,"text":"Protocol DU176B-C-U4001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2024,176],[2434,176],[2434,219],[2024,219]],"region":{"top_left_x":2023,"top_left_y":176,"width":412,"height":44},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4494a95dd463416a9d1e0166af720a96","type":"page_info","conversion_output":false,"text":"Version 4.0, 29 Jul 2019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,260],[2374,260],[2374,301],[309,301]],"region":{"top_left_x":309,"top_left_y":259,"width":2066,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb11fd5b8f6e46d6a4a34b866ae13f4e","type":"text","conversion_output":true,"text":"* Visits may be on-site or at the subject's current place of living, but must be conducted by the investigator or appropriately trained designee (see","text_display":"\n* Visits may be on-site or at the subject's current place of living, but must be conducted by the investigator or appropriately trained designee (see","confidence":0.99951171875,"confidence_rate":0.999996828573223},{"cnt":[[309,305],[492,305],[492,348],[309,348]],"region":{"top_left_x":309,"top_left_y":305,"width":183,"height":44},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ade91ee065d04de8acf33f20b967668c","type":"text","conversion_output":true,"text":"Section 6.4).","text_display":" Section 6.4).","confidence":1,"confidence_rate":1},{"cnt":[[309,370],[2374,370],[2374,410],[309,410]],"region":{"top_left_x":309,"top_left_y":369,"width":2066,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f52879f3462c4652977bfd84da00d892","type":"text","conversion_output":true,"text":"a Subjects eligible to participate in the study provide written IC before randomization or any study-specific procedures. Once written IC is obtained,","text_display":"\na Subjects eligible to participate in the study provide written IC before randomization or any study-specific procedures. Once written IC is obtained,","confidence":1,"confidence_rate":1},{"cnt":[[335,412],[960,412],[960,449],[335,449]],"region":{"top_left_x":335,"top_left_y":412,"width":626,"height":38},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b186406f8eab4fcf83c33e3bec668510","type":"text","conversion_output":true,"text":"subject should be randomized without delay.","text_display":" subject should be randomized without delay.","confidence":1,"confidence_rate":1},{"cnt":[[309,451],[2400,451],[2400,490],[309,490]],"region":{"top_left_x":309,"top_left_y":451,"width":2091,"height":39},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"79285316b9aa429c84967655dd6c03d2","type":"text","conversion_output":true,"text":"b Check the most recent results from local laboratory tests done within the 15 days before randomization against the exclusion criteria. Creatinine and","text_display":"\nb Check the most recent results from local laboratory tests done within the 15 days before randomization against the exclusion criteria. Creatinine and","confidence":0.9770617485046387,"confidence_rate":0.999854064569219},{"cnt":[[335,494],[2344,494],[2344,531],[335,531]],"region":{"top_left_x":335,"top_left_y":494,"width":2009,"height":37},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77116ee5cb10432fa9b00a11fd213f2e","type":"text","conversion_output":true,"text":"CBC must be available from blood draws after TAVI with the subject being clinically stable. CrCL should be calculated by the Cockcroft-Gault","text_display":" CBC must be available from blood draws after TAVI with the subject being clinically stable. CrCL should be calculated by the Cockcroft-Gault","confidence":0.99951171875,"confidence_rate":0.9999966317263753},{"cnt":[[335,533],[2404,533],[2404,571],[335,571]],"region":{"top_left_x":335,"top_left_y":532,"width":2070,"height":40},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19139f88361d408bb578e4954b1d5f4e","type":"text","conversion_output":true,"text":"formula as described in Section 17.7 and the results should be available at each study visit in time to determine correct dosing for Edoxaban subjects.","text_display":" formula as described in Section 17.7 and the results should be available at each study visit in time to determine correct dosing for Edoxaban subjects.","confidence":1,"confidence_rate":1},{"cnt":[[309,571],[2353,571],[2353,612],[309,612]],"region":{"top_left_x":309,"top_left_y":571,"width":2044,"height":42},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"956d3788ebc447fb882507a354fa368b","type":"text","conversion_output":true,"text":"c Contact IXRS for randomization and pre-declaration of oral antiplatelet therapy by drug, dose, and projected last dose if applicable. Also contact","text_display":"\nc Contact IXRS for randomization and pre-declaration of oral antiplatelet therapy by drug, dose, and projected last dose if applicable. Also contact","confidence":1,"confidence_rate":1},{"cnt":[[335,614],[2380,614],[2380,653],[335,653]],"region":{"top_left_x":335,"top_left_y":614,"width":2046,"height":40},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6c492e9e24a44f389dd0fe4ed487f01","type":"text","conversion_output":true,"text":"IXRS for change in Edoxaban dosing, and prior to any distribution of Edoxaban; the end of Edoxaban treatment also needs to be recorded in IXRS.","text_display":" IXRS for change in Edoxaban dosing, and prior to any distribution of Edoxaban; the end of Edoxaban treatment also needs to be recorded in IXRS.","confidence":1,"confidence_rate":1},{"cnt":[[309,653],[2419,653],[2419,694],[309,694]],"region":{"top_left_x":309,"top_left_y":653,"width":2111,"height":41},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"535f1daa87d444638a44e89a691ca6d8","type":"text","conversion_output":true,"text":"d First dose should be should be administered within the 5 days after TAVI (in case of pacemaker deployment within the 7days after TAVI) but within","text_display":"\nd First dose should be should be administered within the 5 days after TAVI (in case of pacemaker deployment within the 7days after TAVI) but within","confidence":0.9799900054931641,"confidence_rate":0.9998696026583055},{"cnt":[[335,696],[2419,696],[2419,737],[335,737]],"region":{"top_left_x":335,"top_left_y":696,"width":2085,"height":41},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b223bd2ac82b453b849e0f8ac6c9efc1","type":"text","conversion_output":true,"text":"24 hours of randomization; however, NO EARLIER than the morning after successful TAVI. For suggested starting dosing see Section 5.2.1.1.1 and","text_display":" 24 hours of randomization; however, NO EARLIER than the morning after successful TAVI. For suggested starting dosing see Section 5.2.1.1.1 and","confidence":1,"confidence_rate":1},{"cnt":[[335,735],[1240,735],[1240,776],[335,776]],"region":{"top_left_x":335,"top_left_y":734,"width":905,"height":42},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a6c611f797e44acb89e9bcb496ea870","type":"text","conversion_output":true,"text":"Section 5.2.1.2.1. Predefine and institute OAP (see Section 3.1).","text_display":" Section 5.2.1.2.1. Predefine and institute OAP (see Section 3.1).","confidence":1,"confidence_rate":1},{"cnt":[[309,778],[2413,778],[2413,814],[309,814]],"region":{"top_left_x":309,"top_left_y":777,"width":2104,"height":38},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a34a0a8322d44a438aab7716562a11a5","type":"text","conversion_output":true,"text":"e Daiichi Sankyo supplies study subjects with Edoxaban. VKA and OAP will be provided or prescribed by the site through the hospital or a physician.","text_display":"\ne Daiichi Sankyo supplies study subjects with Edoxaban. VKA and OAP will be provided or prescribed by the site through the hospital or a physician.","confidence":1,"confidence_rate":1},{"cnt":[[335,816],[935,816],[935,853],[335,853]],"region":{"top_left_x":335,"top_left_y":816,"width":600,"height":37},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6387b4536ed44c648d1b34892558e0de","type":"text","conversion_output":true,"text":"See Section 3.1 about OAP administration.","text_display":" See Section 3.1 about OAP administration.","confidence":1,"confidence_rate":1},{"cnt":[[309,855],[2378,855],[2378,896],[309,896]],"region":{"top_left_x":309,"top_left_y":855,"width":2070,"height":41},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33cde78b869048e6a73a3af6de2622d9","type":"text","conversion_output":true,"text":"f Vital signs include sitting blood pressure and heart rate; body temperature, weight, and height. Height only needs to be recorded at randomization.","text_display":"\nf Vital signs include sitting blood pressure and heart rate; body temperature, weight, and height. Height only needs to be recorded at randomization.","confidence":1,"confidence_rate":1},{"cnt":[[309,900],[1721,900],[1721,939],[309,939]],"region":{"top_left_x":309,"top_left_y":900,"width":1412,"height":39},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f77d82afd8b34651a2012d5fdb32f05b","type":"text","conversion_output":true,"text":"g If 12-lead ECG medically necessary and obtained at any other time, the results need to be recorded.","text_display":"\ng If 12-lead ECG medically necessary and obtained at any other time, the results need to be recorded.","confidence":1,"confidence_rate":1},{"cnt":[[309,941],[2436,941],[2436,982],[309,982]],"region":{"top_left_x":309,"top_left_y":941,"width":2128,"height":41},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de84db2d4731458aad80748849042fe8","type":"text","conversion_output":true,"text":"h Obtain blood samples for analysis of hematology and blood chemistry by a local certified/accredited laboratory (see Section 9.9). Creatinine and CBC","text_display":"\nh Obtain blood samples for analysis of hematology and blood chemistry by a local certified/accredited laboratory (see Section 9.9). Creatinine and CBC","confidence":0.9990234375,"confidence_rate":0.999993696538268},{"cnt":[[335,980],[2383,980],[2383,1021],[335,1021]],"region":{"top_left_x":335,"top_left_y":979,"width":2048,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5fef945787024aef82196e37106f3365","type":"text","conversion_output":true,"text":"must be available from blood draws after TAVI with the patient being clinically stable. CrCL should be calculated by the Cockcroft-Gault formula.","text_display":" must be available from blood draws after TAVI with the patient being clinically stable. CrCL should be calculated by the Cockcroft-Gault formula.","confidence":1,"confidence_rate":1},{"cnt":[[335,1023],[2411,1023],[2411,1059],[335,1059]],"region":{"top_left_x":335,"top_left_y":1022,"width":2076,"height":38},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a368e9a6123040cba11783dc3a742338","type":"text","conversion_output":true,"text":"Normal lab ranges also need to be documented within the eCRF. For Visits 2 and onward. If recent (within 15 days before randomization) lab values","text_display":" Normal lab ranges also need to be documented within the eCRF. For Visits 2 and onward. If recent (within 15 days before randomization) lab values","confidence":1,"confidence_rate":1},{"cnt":[[335,1061],[2176,1061],[2176,1100],[335,1100]],"region":{"top_left_x":335,"top_left_y":1061,"width":1842,"height":39},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bde3680ca19e40aeabe301af3d4fbce5","type":"text","conversion_output":true,"text":"for blood analyses are available through standard of care, these values may be reported and no new sampling or analyses is required.","text_display":" for blood analyses are available through standard of care, these values may be reported and no new sampling or analyses is required.","confidence":1,"confidence_rate":1},{"cnt":[[335,1100],[2430,1100],[2430,1141],[335,1141]],"region":{"top_left_x":335,"top_left_y":1100,"width":2095,"height":41},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cdc3f275304d4b8782e7c38c07c6073f","type":"text","conversion_output":true,"text":"VKA subjects only: INR values and VKA dose are collected (preferably monthly) and entered into the eCRF either during the study visits by local lab","text_display":"\nVKA subjects only: INR values and VKA dose are collected (preferably monthly) and entered into the eCRF either during the study visits by local lab","confidence":0.99951171875,"confidence_rate":0.9999967868439904},{"cnt":[[335,1143],[2378,1143],[2378,1179],[335,1179]],"region":{"top_left_x":335,"top_left_y":1142,"width":2044,"height":38},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05db00bd1ab045bdaa5d9e82659b8748","type":"text","conversion_output":true,"text":"determination (if they haven't already been entered). INR values and VKA doses collected through the general practitioner, a local anticoagulation","text_display":" determination (if they haven't already been entered). INR values and VKA doses collected through the general practitioner, a local anticoagulation","confidence":1,"confidence_rate":1},{"cnt":[[335,1182],[2426,1182],[2426,1220],[335,1220]],"region":{"top_left_x":335,"top_left_y":1181,"width":2091,"height":40},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bbe341ffd435459a9aa3dad98c5ac721","type":"text","conversion_output":true,"text":"clinic, or by the trained and certified patient using a certified device must also be considered and collected. However, this does not constitute a waiver","text_display":" clinic, or by the trained and certified patient using a certified device must also be considered and collected. However, this does not constitute a waiver","confidence":1,"confidence_rate":1},{"cnt":[[335,1220],[2374,1220],[2374,1261],[335,1261]],"region":{"top_left_x":335,"top_left_y":1220,"width":2040,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b25c7af4850147ed8296862410668abb","type":"text","conversion_output":true,"text":"for subject's planned INR determination during study visits. Dose of VKA may need to be adjusted based on these results to maintain INR values","text_display":" for subject's planned INR determination during study visits. Dose of VKA may need to be adjusted based on these results to maintain INR values","confidence":1,"confidence_rate":1},{"cnt":[[335,1261],[2348,1261],[2348,1300],[335,1300]],"region":{"top_left_x":335,"top_left_y":1261,"width":2014,"height":39},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"47878cd8061a42cabafdac1de992c9c1","type":"text","conversion_output":true,"text":"from 2.0 to 3.0 (numbers inclusive) [Japan: 1.6-2.6 in subjects age \\(\\geq 70\\) (numbers inclusive)].Liver function panel will be obtained at Screening","text_display":" from 2.0 to 3.0 (numbers inclusive) [Japan: 1.6-2.6 in subjects age \\(\\geq 70\\) (numbers inclusive)].Liver function panel will be obtained at Screening","confidence":0.9990234375,"confidence_rate":0.9999937768368937},{"cnt":[[335,1302],[2361,1302],[2361,1341],[335,1341]],"region":{"top_left_x":335,"top_left_y":1301,"width":2027,"height":40},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"182cc9206726440daf4992ee9bce608d","type":"text","conversion_output":true,"text":"(unless recent, within the last 15 days, results are available), and at the 6 and 12 Month Visits, unless clinically necessary at other time points.","text_display":" (unless recent, within the last 15 days, results are available), and at the 6 and 12 Month Visits, unless clinically necessary at other time points.","confidence":0.99755859375,"confidence_rate":0.9999849112783928},{"cnt":[[309,1341],[2396,1341],[2396,1381],[309,1381]],"region":{"top_left_x":309,"top_left_y":1340,"width":2087,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28d2c8af99f9408390925df759c65839","type":"text","conversion_output":true,"text":"i PACT-Q1 and EQ-5D-5L at Randomization, PACT-Q2 and EQ-5D-5L at 3 months and again at either 12 months or at EOT, whichever comes first.","text_display":"\ni PACT-Q1 and EQ-5D-5L at Randomization, PACT-Q2 and EQ-5D-5L at 3 months and again at either 12 months or at EOT, whichever comes first.","confidence":0.99951171875,"confidence_rate":0.9999967000020794},{"cnt":[[335,1384],[1330,1384],[1330,1420],[335,1420]],"region":{"top_left_x":335,"top_left_y":1383,"width":995,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e069af30c774a13abd3c0627812d797","type":"text","conversion_output":true,"text":"Forms will be collected by the CRO for uploading into the data system.","text_display":" Forms will be collected by the CRO for uploading into the data system.","confidence":0.99951171875,"confidence_rate":0.9999934880145617},{"cnt":[[305,1422],[2365,1422],[2365,1463],[305,1463]],"region":{"top_left_x":305,"top_left_y":1422,"width":2061,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1b6dcc5a8004a73889bfac9dcd4a9fd","type":"text","conversion_output":true,"text":"j Antithrombotic regimen compliance is evaluated at each visit/telephone assessment (both by pill count, self-reporting/physician-reporting, subject","text_display":"\nj Antithrombotic regimen compliance is evaluated at each visit/telephone assessment (both by pill count, self-reporting/physician-reporting, subject","confidence":0.99951171875,"confidence_rate":0.9999968078449766},{"cnt":[[335,1465],[2426,1465],[2426,1504],[335,1504]],"region":{"top_left_x":335,"top_left_y":1465,"width":2091,"height":39},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13cfc008bee540b88f8d46e9903a9332","type":"text","conversion_output":true,"text":"medication log, and for VKA subjects only, by INR values). In case of a suspected study endpoint, an additional assessment for subject compliance to","text_display":" medication log, and for VKA subjects only, by INR values). In case of a suspected study endpoint, an additional assessment for subject compliance to","confidence":1,"confidence_rate":1},{"cnt":[[335,1504],[913,1504],[913,1543],[335,1543]],"region":{"top_left_x":335,"top_left_y":1503,"width":579,"height":40},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d31506b8ec184887aae249bd3c55172c","type":"text","conversion_output":true,"text":"the assigned regimen must be performed.","text_display":" the assigned regimen must be performed.","confidence":1,"confidence_rate":1},{"cnt":[[309,1543],[2383,1543],[2383,1583],[309,1583]],"region":{"top_left_x":309,"top_left_y":1542,"width":2074,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"704bd1d82e8a4734a9b1bd1bc2c4a7c8","type":"text","conversion_output":true,"text":"k Assessment and recording of (S)AEs and suspected clinical events from the signing of the informed consent, and should be reported as soon as site","text_display":"\nk Assessment and recording of (S)AEs and suspected clinical events from the signing of the informed consent, and should be reported as soon as site","confidence":0.99951171875,"confidence_rate":0.999996828573223},{"cnt":[[335,1586],[2297,1586],[2297,1622],[335,1622]],"region":{"top_left_x":335,"top_left_y":1585,"width":1962,"height":38},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f644b294585413baa84f96bacf98237","type":"text","conversion_output":true,"text":"personnel learn of the event and be reported within 24 h of the Investigator's/site's awareness. Endpoint event and AE reporting should occur","text_display":" personnel learn of the event and be reported within 24 h of the Investigator's/site's awareness. Endpoint event and AE reporting should occur","confidence":0.9666893665244061,"confidence_rate":0.9997756670912918},{"cnt":[[335,1624],[2391,1624],[2391,1663],[335,1663]],"region":{"top_left_x":335,"top_left_y":1624,"width":2057,"height":39},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0bec0912bf847709bcfd0a70a970809","type":"text","conversion_output":true,"text":"throughout the study and not be restricted to specific visits. If AST or ALT > 3xULN with simultaneous total bilirubin levels > 2xULN is observed,","text_display":" throughout the study and not be restricted to specific visits. If AST or ALT > 3xULN with simultaneous total bilirubin levels > 2xULN is observed,","confidence":0.9834635257720947,"confidence_rate":0.9998895774348342},{"cnt":[[335,1663],[1721,1663],[1721,1704],[335,1704]],"region":{"top_left_x":335,"top_left_y":1662,"width":1386,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3480f339ea444342a179c8b5411c7922","type":"text","conversion_output":true,"text":"then ALP should be determined. Hospitalization due to cardiovascular events needs to be assessed.","text_display":" then ALP should be determined. Hospitalization due to cardiovascular events needs to be assessed.","confidence":1,"confidence_rate":1},{"cnt":[[309,1704],[2361,1704],[2361,1742],[309,1742]],"region":{"top_left_x":309,"top_left_y":1703,"width":2053,"height":40},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21352af202f344469e3c86d4d7c2cddf","type":"text","conversion_output":true,"text":"1 When subjects are being transitioned to non-study medications, record the date and time of last administration of study medication, and collect all","text_display":"\n1 When subjects are being transitioned to non-study medications, record the date and time of last administration of study medication, and collect all","confidence":1,"confidence_rate":1},{"cnt":[[335,1745],[2357,1745],[2357,1785],[335,1785]],"region":{"top_left_x":335,"top_left_y":1744,"width":2022,"height":42},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1744231eebf0450192b85febc4c1d73c","type":"text","conversion_output":true,"text":"unused study medication. Subjects are transitioned to an approved OAC of the Investigator's or treating physician's choice. The Investigator will","text_display":" unused study medication. Subjects are transitioned to an approved OAC of the Investigator's or treating physician's choice. The Investigator will","confidence":1,"confidence_rate":1},{"cnt":[[335,1785],[2430,1785],[2430,1824],[335,1824]],"region":{"top_left_x":335,"top_left_y":1785,"width":2095,"height":40},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a136685946c4a4fb87de0997a6d6964","type":"text","conversion_output":true,"text":"follow the transition strategy in the approved product label. Subjects who prematurely discontinue study OAC are requested to also complete the Post-","text_display":" follow the transition strategy in the approved product label. Subjects who prematurely discontinue study OAC are requested to also complete the Post","confidence":1,"confidence_rate":1},{"cnt":[[335,1826],[1708,1826],[1708,1865],[335,1865]],"region":{"top_left_x":335,"top_left_y":1826,"width":1374,"height":39},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01cee1751bdf4b74898e63ac7e731c0f","type":"text","conversion_output":true,"text":"treatment Follow-up Visit according to this schedule (See Section 5.2.1.1.2 and Section 5.2.1.2.2).","text_display":"treatment Follow-up Visit according to this schedule (See Section 5.2.1.1.2 and Section 5.2.1.2.2).","confidence":1,"confidence_rate":1},{"cnt":[[1130,1904],[1618,1904],[1618,1957],[1130,1957]],"region":{"top_left_x":1130,"top_left_y":1903,"width":488,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdcead3e0b1f4d8b84d8aae3ce9beaf9","type":"section_header","conversion_output":false,"children_ids":["00cf636ed07c4d73b599c96213904002"],"text":"","text_display":""},{"cnt":[[1134,1908],[1613,1908],[1613,1953],[1134,1953]],"region":{"top_left_x":1134,"top_left_y":1907,"width":480,"height":46},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00cf636ed07c4d73b599c96213904002","type":"text","conversion_output":true,"parent_id":"cdcead3e0b1f4d8b84d8aae3ce9beaf9","text":"Proprietary and Confidential","text_display":"\n\n\\section*{Proprietary and Confidential}","confidence":1,"confidence_rate":1},{"cnt":[[1293,1955],[1454,1955],[1454,2004],[1293,2004]],"region":{"top_left_x":1293,"top_left_y":1955,"width":162,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a85612ec393448b8378ff744e6481c4","type":"page_info","conversion_output":false,"text":"Page 106","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"26e08de1-160a-4741-ac91-a7799d6d9159-107","page":107,"lines":[{"cnt":[[56,37],[930,37],[930,73],[56,73]],"region":{"top_left_x":55,"top_left_y":36,"width":876,"height":38},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"69c87cab085a47f7b0f69b45eb8982a1","type":"page_info","conversion_output":false,"text":"DocuSign Envelope ID: A990BBB0-071F-4B3E-820D-891DBA7FBEF1","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[1964,129],[2436,129],[2436,168],[1964,168]],"region":{"top_left_x":1963,"top_left_y":128,"width":474,"height":40},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20b1379d388546fcb90d8eec940f2bee","type":"page_info","conversion_output":false,"text":"Protocol DU176B-C-U4001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2024,176],[2436,176],[2436,219],[2024,219]],"region":{"top_left_x":2023,"top_left_y":176,"width":414,"height":44},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"051304ce51844983b55846d0a7007ade","type":"page_info","conversion_output":false,"text":"Version 4.0, 29 Jul 2019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,251],[2254,251],[2254,292],[309,292]],"region":{"top_left_x":309,"top_left_y":251,"width":1945,"height":42},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa4d0131b9d24252ac9950f0775b407c","type":"text","conversion_output":true,"text":"m EOT may occur at any time (e.g., at subject withdrawal or discontinuation) and will trigger this subject's Post-treatment Follow-up Visit.","text_display":"\nm EOT may occur at any time (e.g., at subject withdrawal or discontinuation) and will trigger this subject's Post-treatment Follow-up Visit.","confidence":0.9878182271495461,"confidence_rate":0.9999154754428937},{"cnt":[[309,292],[1038,292],[1038,333],[309,333]],"region":{"top_left_x":309,"top_left_y":292,"width":729,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b87f13f7e764289afa7f61ebbe121a4","type":"text","conversion_output":true,"text":"n Female subject who are of child bearing potential.","text_display":" n Female subject who are of child bearing potential.","confidence":0.99755859375,"confidence_rate":0.9999585704965006},{"cnt":[[309,331],[2310,331],[2310,372],[309,372]],"region":{"top_left_x":309,"top_left_y":330,"width":2001,"height":42},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1a16f1c4f5e47248fca66732489e5c7","type":"text","conversion_output":true,"text":"o Female subject who are of child bearing potential. Furthermore, pregnancy tests are carried out whenever there are clinical indications for the","text_display":"\no Female subject who are of child bearing potential. Furthermore, pregnancy tests are carried out whenever there are clinical indications for the","confidence":0.99951171875,"confidence_rate":0.99999674400198},{"cnt":[[333,372],[694,372],[694,415],[333,415]],"region":{"top_left_x":333,"top_left_y":371,"width":361,"height":44},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6bb9f7fbf8f94e85872966a4ed3b0c33","type":"text","conversion_output":true,"text":"existence of a pregnancy.","text_display":" existence of a pregnancy.","confidence":1,"confidence_rate":1},{"cnt":[[305,412],[2421,412],[2421,453],[305,453]],"region":{"top_left_x":305,"top_left_y":412,"width":2117,"height":42},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d31dd89f8b9d45e38fa5429065fe35ab","type":"text","conversion_output":true,"text":"p All subjects who have taken study medication should be requested to consent for routine follow-up contact at 6-month intervals following termination","text_display":"\np All subjects who have taken study medication should be requested to consent for routine follow-up contact at 6-month intervals following termination","confidence":0.994631290435791,"confidence_rate":0.999965270455505},{"cnt":[[333,451],[2348,451],[2348,492],[333,492]],"region":{"top_left_x":333,"top_left_y":451,"width":2016,"height":41},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"975877559a1e4638a590c5cfd084cb9d","type":"text","conversion_output":true,"text":"of study drug. This will normally be as a phone contact until the end of the study is determined by the Sponsor. Should the subject choose to not","text_display":" of study drug. This will normally be as a phone contact until the end of the study is determined by the Sponsor. Should the subject choose to not","confidence":1,"confidence_rate":1},{"cnt":[[333,490],[2146,490],[2146,535],[333,535]],"region":{"top_left_x":333,"top_left_y":489,"width":1814,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec3bb06c5ed44095a7e9956c9bd19e25","type":"text","conversion_output":true,"text":"receive phone calls, the site may attempt to retrieve this information from viewing the subject's medical records or public records.","text_display":" receive phone calls, the site may attempt to retrieve this information from viewing the subject's medical records or public records.","confidence":1,"confidence_rate":1},{"cnt":[[1130,1904],[1613,1904],[1613,1957],[1130,1957]],"region":{"top_left_x":1130,"top_left_y":1903,"width":484,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"318ed8ba3ff34cdcac026b6a7877ee62","type":"page_info","conversion_output":false,"text":"Proprietary and Confidential","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1293,1955],[1454,1955],[1454,2004],[1293,2004]],"region":{"top_left_x":1293,"top_left_y":1955,"width":162,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"314ad2e2da9244f8930353d324260c8c","type":"page_info","conversion_output":false,"text":"Page 107","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2125,"page_width":2750,"languages_detected":[]},{"image_id":"26e08de1-160a-4741-ac91-a7799d6d9159-108","page":108,"lines":[{"cnt":[[54,34],[930,34],[930,71],[54,71]],"region":{"top_left_x":53,"top_left_y":34,"width":878,"height":37},"line":1,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"1afb9f26559346faaabcc9b4619b0488","type":"page_info","conversion_output":false,"text":"DocuSign Envelope ID: A990BBB0-071F-4B3E-820D-891DBA7FBEF1","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999844953424807},{"cnt":[[1336,129],[1813,129],[1813,170],[1336,170]],"region":{"top_left_x":1336,"top_left_y":128,"width":478,"height":42},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3186ad49444547c2b609159d5be73e61","type":"page_info","conversion_output":false,"text":"Protocol DU176B-C-U4001","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1399,176],[1811,176],[1811,221],[1399,221]],"region":{"top_left_x":1398,"top_left_y":176,"width":414,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d99dc27f5c714da2bd5904e0d0d1f21f","type":"page_info","conversion_output":false,"text":"Version 4.0, 29 Jul 2019","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,292],[866,292],[866,352],[305,352]],"region":{"top_left_x":305,"top_left_y":292,"width":561,"height":61},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c9d717014d24389bd64abef486ae35c","type":"section_header","conversion_output":false,"children_ids":["49918270256e44a1bcb0735415bb62a6"],"text":"","text_display":""},{"cnt":[[309,296],[862,296],[862,350],[309,350]],"region":{"top_left_x":309,"top_left_y":296,"width":553,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49918270256e44a1bcb0735415bb62a6","type":"text","conversion_output":true,"parent_id":"2c9d717014d24389bd64abef486ae35c","text":"17.1. Bleeding Criteria","text_display":"\n\n\\subsection*{17.1. Bleeding Criteria}","confidence":0.654296875,"confidence_rate":0.9849643916788213},{"cnt":[[305,391],[926,391],[926,445],[305,445]],"region":{"top_left_x":305,"top_left_y":391,"width":621,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cc98af6b23f438e87330d86edd5eb21","type":"section_header","conversion_output":false,"children_ids":["b6b17ab168674600bbe1bbd0a0dd66da"],"text":"","text_display":""},{"cnt":[[309,391],[922,391],[922,440],[309,440]],"region":{"top_left_x":309,"top_left_y":391,"width":613,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6b17ab168674600bbe1bbd0a0dd66da","type":"text","conversion_output":true,"parent_id":"6cc98af6b23f438e87330d86edd5eb21","text":"17.1.1. ISTH Bleeding Criteria","text_display":"\n\n\\subsection*{17.1.1. ISTH Bleeding Criteria}","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[305,455],[1016,455],[1016,513],[305,513]],"region":{"top_left_x":305,"top_left_y":455,"width":712,"height":59},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43438825c2b44da7b37b7747715a5509","type":"figure_label","conversion_output":false,"text":"Table 17.2: ISTH Bleeding Criteria \\({ }^{27}\\)","text_display":"","confidence":0.99951171875,"confidence_rate":0.999989825041388},{"cnt":[[309,522],[1820,522],[1820,1590],[309,1590]],"region":{"top_left_x":309,"top_left_y":522,"width":1511,"height":1068},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e59ffedba5c4de9818d3d31d5d9f93a","type":"table","conversion_output":true,"children_ids":["6326e6c796964bc2b5d8df3cc56ab67d","e434020e418149a5b7a1511342efa79b","b78a90dbcc93415aa41d24b73c676c8e","7fe3190bef814cb09dc7d95c7643cc1d","b2a29370c3a84319ad6e3f27e57dacaf","06ad5dc6504a457cb707c9016bc0b9cf","455d86f5906849e8a017958367aaf4ac"],"selected_labels":["43438825c2b44da7b37b7747715a5509"],"text":"\\begin{tabular}{|l|}\n\\hline ISTH Bleeding Criteria \\\\\n\\hline \\begin{tabular}{l}\nMajor bleeding \\\\\n- Clinically overt bleeding that is associated with: \\\\\n- A fall in hemoglobin of \\(2 g / dL (1.24 mmol / L )\\) or more, or \\\\\n- A transfusion of 2 or more units of whole blood or packed red blood cells, or \\\\\n- Symptomatic bleeding in a critical site or organ such as: intracranial, intraspinal, intraocular, retroperitoneal, pericardial, intra-articular, intramuscular with compartment syndrome, or \\\\\n- A fatal outcome\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nClinically relevant non-major (CRNM) bleeding \\\\\n- Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: \\\\\n- requiring medical intervention by a healthcare professional \\\\\n- leading to hospitalization or increased level of care \\\\\n- prompting a face to face (i.e., not just a telephone or electronic communication) evaluation. \\\\\nMinor \\\\\n- Bleeding episodes not requiring any medical attention and therefore not meeting the criteria for major or clinically relevant non-major bleeding.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 17.2: ISTH Bleeding Criteria \\({ }^{27}\\)}\n\\begin{tabular}{|l|}\n\\hline ISTH Bleeding Criteria \\\\\n\\hline \\begin{tabular}{l}\nMajor bleeding \\\\\n- Clinically overt bleeding that is associated with: \\\\\n- A fall in hemoglobin of \\(2 g / dL (1.24 mmol / L )\\) or more, or \\\\\n- A transfusion of 2 or more units of whole blood or packed red blood cells, or \\\\\n- Symptomatic bleeding in a critical site or organ such as: intracranial, intraspinal, intraocular, retroperitoneal, pericardial, intra-articular, intramuscular with compartment syndrome, or \\\\\n- A fatal outcome\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nClinically relevant non-major (CRNM) bleeding \\\\\n- Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by 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more units of whole blood or packed red blood cells, or \\\\\n- Symptomatic bleeding in a critical site or organ such as: intracranial, intraspinal, intraocular, retroperitoneal, pericardial, intra-articular, intramuscular with compartment syndrome, or \\\\\n- A fatal outcome\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nMajor bleeding \\\\\n- Clinically overt bleeding that is associated with: \\\\\n- A fall in hemoglobin of \\(2 g / dL (1.24 mmol / L )\\) or more, or \\\\\n- A transfusion of 2 or more units of whole blood or packed red blood cells, or \\\\\n- Symptomatic bleeding in a critical site or organ such as: intracranial, intraspinal, intraocular, retroperitoneal, pericardial, intra-articular, intramuscular with compartment syndrome, or \\\\\n- A fatal 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intracranial,","confidence":0.99853515625,"confidence_rate":0.9999812063601604},{"cnt":[[609,822],[1630,822],[1630,866],[609,866]],"region":{"top_left_x":609,"top_left_y":822,"width":1021,"height":44},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d4bb084ca544e86b3d3b3813c658f31","type":"text","conversion_output":false,"parent_id":"06ad5dc6504a457cb707c9016bc0b9cf","text":"intraspinal, intraocular, retroperitoneal, pericardial, intra-articular,","text_display":" intraspinal, intraocular, retroperitoneal, pericardial, intra-articular,","confidence":1,"confidence_rate":1},{"cnt":[[609,866],[1332,866],[1332,909],[609,909]],"region":{"top_left_x":609,"top_left_y":865,"width":724,"height":45},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c369ceaf73543b297452728b948a2e8","type":"text","conversion_output":false,"parent_id":"06ad5dc6504a457cb707c9016bc0b9cf","text":"intramuscular with compartment syndrome, 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intervention by a healthcare professional \\\\\n- leading to hospitalization or increased level of care \\\\\n- prompting a face to face (i.e., not just a telephone or electronic communication) evaluation. \\\\\nMinor \\\\\n- Bleeding episodes not requiring any medical attention and therefore not meeting the criteria for major or clinically relevant non-major bleeding.\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.89892578125,"confidence_rate":0.9997131512786288},{"cnt":[[325,1002],[1196,1002],[1196,1051],[325,1051]],"region":{"top_left_x":325,"top_left_y":1002,"width":871,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0ee0621eb174028ad23e40df051efc6","type":"text","conversion_output":false,"parent_id":"455d86f5906849e8a017958367aaf4ac","text":"Clinically relevant non-major (CRNM) bleeding","text_display":"Clinically relevant non-major (CRNM) 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blood.","confidence":1,"confidence_rate":1},{"cnt":[[395,778],[1390,778],[1390,827],[395,827]],"region":{"top_left_x":395,"top_left_y":777,"width":996,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a017bbc6a0054a88ac2ae4d7f1e40106","type":"text","conversion_output":true,"text":"- Pathological findings of an acute myocardial infarction.","text_display":"\n- Pathological findings of an acute myocardial infarction.","confidence":1,"confidence_rate":1},{"cnt":[[303,928],[1729,928],[1729,1023],[303,1023]],"region":{"top_left_x":302,"top_left_y":928,"width":1428,"height":95},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6fdbe10a0b84720be66c7a16447480b","type":"figure_label","conversion_output":false,"children_ids":["719344a9509041f59bc5dcea422339bc","b8d72d0ac48e4256abf9dfc8ba04277a"],"text":"","text_display":""},{"cnt":[[309,930],[1725,930],[1725,978],[309,978]],"region":{"top_left_x":309,"top_left_y":930,"width":1417,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"719344a9509041f59bc5dcea422339bc","type":"text","conversion_output":false,"parent_id":"b6fdbe10a0b84720be66c7a16447480b","text":"Table 17.4: Myocardial Infarction (MI) According to the ESC 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intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis. The patient may have underlying severe coronary artery disease (CAD) but on occasion nonobstructive or no CAD. Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac Troponin (cTn)) with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: \\\\\n- Symptoms of ischemia \\\\\n- (Presumed) new significant ST-T wave changes or new left bundle branch block (LBBB) \\\\\n- Development of pathological Q waves \\\\\n- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality \\\\\n- Identification of an intracoronary thrombus by angiography or autopsy\n\\end{tabular} \\\\\n\\hline 2 & \\begin{tabular}{l}\nIn instances of myocardial injury with necrosis where a condition other than CAD contributes to an imbalance between myocardial oxygen supply and/or demand, e.g. coronary endothelial dysfunction, coronary artery spasm, coronary embolism, tachy-/brady-arrhythmias, anemia, respiratory failure, hypotension, and hypertension with or without LVH. 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The patient may have underlying severe coronary artery disease (CAD) but on occasion nonobstructive or no CAD. 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The patient may","text_display":" flow or distal platelet emboli with ensuing myocyte necrosis. The patient may","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[443,1290],[1723,1290],[1723,1336],[443,1336]],"region":{"top_left_x":443,"top_left_y":1290,"width":1280,"height":47},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddc89938192c417e88fb12e8641c24ec","type":"text","conversion_output":false,"parent_id":"855ddc65f49d4383b836cf89724cf41a","text":"have underlying severe coronary artery disease (CAD) but on occasion non-","text_display":" have underlying severe coronary artery disease (CAD) but on occasion non","confidence":0.99951171875,"confidence_rate":0.9999937384747559},{"cnt":[[443,1339],[1701,1339],[1701,1380],[443,1380]],"region":{"top_left_x":443,"top_left_y":1339,"width":1259,"height":42},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"086d907f1bd74a6da64f9f2c380b3d5e","type":"text","conversion_output":false,"parent_id":"855ddc65f49d4383b836cf89724cf41a","text":"obstructive or no CAD. 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instances of myocardial injury with necrosis where a condition other than CAD contributes to an imbalance between myocardial oxygen supply and/or demand, e.g. coronary endothelial dysfunction, coronary artery spasm, coronary embolism, tachy-/brady-arrhythmias, anemia, respiratory failure, hypotension, and hypertension with or without LVH. Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac Troponin (cTn)) with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: \\\\\n- Symptoms of ischemia \\\\\n- (Presumed) new significant ST-T wave changes or new LBBB \\\\\n- Development of pathological Q waves \\\\\n- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nIn instances of myocardial injury with necrosis where a condition other than CAD contributes to an imbalance between myocardial oxygen supply and/or demand, e.g. coronary endothelial dysfunction, coronary artery spasm, coronary embolism, tachy-/brady-arrhythmias, anemia, respiratory failure, hypotension, and hypertension with or without LVH. Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac Troponin (cTn)) with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: \\\\\n- Symptoms of ischemia \\\\\n- (Presumed) new significant ST-T wave changes or new LBBB \\\\\n- Development of pathological Q waves \\\\\n- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.8056640625,"confidence_rate":0.999789689503467},{"cnt":[[443,1836],[1728,1836],[1728,1882],[443,1882]],"region":{"top_left_x":443,"top_left_y":1835,"width":1286,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4134d1fb082c4f7ab12df4cdb1a2f803","type":"text","conversion_output":false,"parent_id":"f81bcae650824d1aae08a4ff7ba11746","text":"In instances of myocardial injury with necrosis where a condition other than","text_display":"In instances of myocardial injury with necrosis where a condition other than","confidence":0.8056640625,"confidence_rate":0.9973357970422783},{"cnt":[[443,1885],[1731,1885],[1731,1931],[443,1931]],"region":{"top_left_x":443,"top_left_y":1884,"width":1289,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aacc6ffc038b4b40a25da0adfc962c56","type":"text","conversion_output":false,"parent_id":"f81bcae650824d1aae08a4ff7ba11746","text":"CAD contributes to an imbalance between myocardial oxygen supply and/or","text_display":" CAD contributes to an imbalance between myocardial oxygen supply and/or","confidence":0.9990234375,"confidence_rate":0.9999871442977954},{"cnt":[[443,1928],[1788,1928],[1788,1980],[443,1980]],"region":{"top_left_x":443,"top_left_y":1928,"width":1346,"height":53},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c04d68ed93944549261828f574f256a","type":"text","conversion_output":false,"parent_id":"f81bcae650824d1aae08a4ff7ba11746","text":"demand, e.g. coronary endothelial dysfunction, coronary artery spasm, coronary","text_display":" demand, e.g. coronary endothelial dysfunction, coronary artery spasm, coronary","confidence":1,"confidence_rate":1},{"cnt":[[443,1978],[1756,1978],[1756,2027],[443,2027]],"region":{"top_left_x":443,"top_left_y":1977,"width":1313,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f44bd4a1306b4fd8b9b7863f145ff51a","type":"text","conversion_output":false,"parent_id":"f81bcae650824d1aae08a4ff7ba11746","text":"embolism, tachy-/brady-arrhythmias, anemia, respiratory failure, hypotension,","text_display":" embolism, tachy-/brady-arrhythmias, anemia, respiratory failure, hypotension,","confidence":0.99560546875,"confidence_rate":0.9999462914961955},{"cnt":[[443,2027],[1788,2027],[1788,2073],[443,2073]],"region":{"top_left_x":443,"top_left_y":2026,"width":1346,"height":48},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"413d232fb47f46d197c1eee4add9faf4","type":"text","conversion_output":false,"parent_id":"f81bcae650824d1aae08a4ff7ba11746","text":"and hypertension with or without LVH. Detection of a rise and/or fall of cardiac","text_display":" and hypertension with or without LVH. Detection of a rise and/or fall of cardiac","confidence":1,"confidence_rate":1},{"cnt":[[443,2076],[1734,2076],[1734,2122],[443,2122]],"region":{"top_left_x":443,"top_left_y":2075,"width":1291,"height":48},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37c8b45002bb46d98be6826af54036d3","type":"text","conversion_output":false,"parent_id":"f81bcae650824d1aae08a4ff7ba11746","text":"biomarker values (preferably cardiac Troponin (cTn)) with at least one value","text_display":" biomarker values (preferably cardiac Troponin (cTn)) with at least one value","confidence":1,"confidence_rate":1},{"cnt":[[443,2122],[1810,2122],[1810,2171],[443,2171]],"region":{"top_left_x":443,"top_left_y":2122,"width":1368,"height":50},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"191f20e2d1e644d5bb0079af1c308d62","type":"text","conversion_output":false,"parent_id":"f81bcae650824d1aae08a4ff7ba11746","text":"above the 99th percentile upper 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Type & \\\\\n\\hline & Identification of an intracoronary thrombus by angiography or autopsy \\\\\n\\hline 3 & Cardiac death with symptoms suggestive of MI and presumed new ischemic ECG changes or new LBBB, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased \\\\\n\\hline 4a & Percutaneous coronary intervention (PCI) related MI is arbitrarily defined by elevation of cTn values (>5 X 99th percentile URL) in patients with normal baseline values ( \\(\\leq 99\\) th percentile URL) or a rise of cTn values \\(>20 \\%\\) if the baseline values are elevated and are stable or falling. In addition, either (i) symptoms suggestive of myocardial ischemia or (ii) new ischemic ECG changes or (iii) angiographic findings consistent with a procedural complication or (iv) imaging demonstration of new loss of viable myocardium or new regional wall motion abnormality are required. \\\\\n\\hline 4b & Stent thrombosis associated with MI when detected by coronary angiography or autopsy in the setting of myocardial ischemia and with a rise and/or fall of cardiac biomarker values with at least one value above the 99th percentile URL. \\\\\n\\hline 5 & Coronary artery bypass grafting (CABG) related MI is arbitrarily defined by elevation of cardiac biomarker values ( \\(>10 X\\) 99th percentile URL) in patients with normal baseline cTn values ( \\(\\leq 99\\) th percentile URL). In addition, either (i) new pathological Q waves or new LBBB, or (ii) angiographic documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Type & \\\\\n\\hline & Identification of an intracoronary thrombus by angiography or autopsy \\\\\n\\hline 3 & Cardiac death with symptoms suggestive of MI and presumed new ischemic ECG changes or new LBBB, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased \\\\\n\\hline 4a & Percutaneous coronary intervention (PCI) related MI is arbitrarily defined by elevation of cTn values (>5 X 99th percentile URL) in patients with normal baseline values ( \\(\\leq 99\\) th percentile URL) or a rise of cTn values \\(>20 \\%\\) if the baseline values are elevated and are stable or falling. In addition, either (i) symptoms suggestive of myocardial ischemia or (ii) new ischemic ECG changes or (iii) angiographic findings consistent with a procedural complication or (iv) imaging demonstration of new loss of viable myocardium or new regional wall motion abnormality are required. \\\\\n\\hline 4b & Stent thrombosis associated with MI when detected by coronary angiography or autopsy in the setting of myocardial ischemia and with a rise and/or fall of cardiac biomarker values with at least one value above the 99th percentile URL. \\\\\n\\hline 5 & Coronary artery bypass grafting (CABG) related MI is arbitrarily defined by elevation of cardiac biomarker values ( \\(>10 X\\) 99th percentile URL) in patients with normal baseline cTn values ( \\(\\leq 99\\) th percentile URL). In addition, either (i) new pathological Q waves or new LBBB, or (ii) angiographic documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. 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